The FDA eSTAR requires you to attach human clinical study reports and summarize how it supports substantial equivalence.
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Human Clinical Study Webinar ($79)
Human Clinical Study Webinar
In this webinar you will learn how to prepare your summary of human clinical studies, including the format for the GCP testing report and where this information is included in your FDA eSTAR.
Price: $79.00
When is the Human Clinical Study Webinar?
This webinar was live on Thursday, February 8, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
Why you should register for the Human Clinical Study Webinar?
You will learn where your human clinical study information is attached in the FDA eSTAR, what additional information you need to attach to the eSTAR template, and how to answer questions about:
Patient-reported outcomes (PROs)
Patient-preference information (PPI)
GCP Statement of Compliance
Waiver requests for OUS studies
We will also discuss what questions to ask the FDA during a pre-submission meeting to ensure you do not need to repeat your human clinical study.
What you will receive:
an invitation to participate in the live webinar (if you purchase prior to February 8)
a recording of the webinar you can replay anytime
the most recent version of the template for human clinical study protocols (see SYS-009)
the native slide deck for this webinar
If you would like to ask specific questions about preparing the human clinical studies, please submit them via email or schedule a call using the calendly app on our contact us page.All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Human Clinical Study Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email.You can also follow him on YouTube,LinkedIn, or Twitter.
The FDA eSTAR requires you to attach animal performance testing reports and summarize how it supports substantial equivalence.
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Animal Performance Testing Webinar ($79)
Animal Performance Testing Webinar
In this webinar you will learn how to prepare your summary of animal performance testing, including the format for the GLP testing report and where this information is included in your FDA eSTAR.
Price: $79.00
When is the Animal Performance Testing Webinar?
This webinar was live on Thursday, February 1. The session will also be recorded. You can purchase it on-demand and watch the training as many times as you wish.
Why you should register for the Animal Performance Testing Webinar
You will learn where your Animal performance testing information is attached in the FDA eSTAR on how to prepare a non-clinical performance GLP testing report. We will also discuss what questions to ask the FDA during a pre-submission meeting to make sure that you do not need to repeat your testing.
What you will receive
an invitation to participate in the live webinar (if you purchase prior to February 1)
a recording of the webinar you can replay anytime
the most recent version of the template for Animal Performance Testing Reports
the native slide deck for this webinar
If you would like to ask specific questions about preparing the Animal Performance Testing reports, please submit them via email or schedule a call using the calendly app on our contact us page.All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Animal Performance Testing Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email.You can also follow him onGoogle+,LinkedIn, or Twitter.
The FDA eSTAR requires you to attach benchtop performance testing reports and summarize how it supports substantial equivalence.
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Benchtop Performance Testing Webinar ($79)
Benchtop Performance Testing Webinar
In this webinar you will learn how to prepare your summary of non-clinical benchtop performance testing, including the format for the testing report and where this information is included in your FDA eSTAR.
Price: $79.00
When is the Benchtop Performance Testing Webinar?
This webinar was live on Thursday, January 25. The session will also be recorded. You can purchase it on-demand and watch the training as many times as you wish.
Why you should register for the Benchtop Performance Testing Webinar
You will learn where your benchtop performance testing information is attached in the FDA eSTAR on how to prepare a non-clinical performance testing report. We will also discuss what questions to ask the FDA during a pre-submission meeting to make sure that you do not need to repeat your testing.
What you will receive
an invitation to participate in the live webinar (if you purchase prior to January 25)
a recording of the webinar you can replay anytime
the most recent version of the template for Benchtop Performance Testing Reports
the native slide deck for this webinar
If you would like to ask specific questions about preparing the Benchtop Performance Testing reports, please submit them via email or schedule a call using the calendly app on our contact us page.All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Benchtop Performance Testing Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email.You can also follow him onGoogle+,LinkedIn, or Twitter.
Our team has saved links to some of the most common regulatory requirements for regulatory submissions and compliance.
How do you keep track of the regulatory requirements?
Keeping track of all the global regulatory requirements on your computer desktop is nearly impossible, but you don’t have to. Medical Device Academy’s consulting team saved the links to the most common regulatory resources for regulatory submissions and compliance. The links should be up-to-date because we use this page ourselves. However, please don’t hesitate to let us know if you find a broken link or if you want us to add the links for another country. Just let us know which regulatory requirements you’re looking for on our suggestion portal page.
This 510k software documentation webinar defines the new FDA eSTAR documentation required for software and cybersecurity.
510(k) Software Documentation Webinar – Free
This webinar was created in 2019, but Rob Packard is presenting an updated version on March 7, 2024, to address the new requirements of the FDA eSTAR template (v5.1) in the software and cybersecurity sections. If you cannot attend the live session, we will record it and provide you with a download link if you fill out the form below.
When is the 510k Software Documentation Webinar?
The live webinar is scheduled for March 7, 2024 @ 10:30 am ET. If you fill out the form above before the live presentation, you will receive a link to participate in the live webinar via Zoom. For SaMD and SiMD, modify your design plan to integrate 510(k) software documentation requirements and cybersecurity documentation requirements. Specifically, the new FDA eSTAR requires 10 different document types to be attached for software documentation and 12 different document types to be attached for cybersecurity. The most important thing to consider is which documents must be created before you start coding and which are created only after you are done coding. The documents can and will be revised and edited during the software development. Still, your project will not be successful if you don’t build the proper foundation for the project by creating a few critical documents before your team starts coding. This webinar is also applicable to software as a medical device (SaMD).
510(k) Software Documentation Webinar
Risk Documentation Level – The FDA no longer uses the term “Level of Concern” and the level of software risk documentation were simplified to “Basic Documentation” and “Enhanced Documentation.” You only need to justify why your software does not fall within the criteria for “Enhanced Documentation.” We also provide a template for this in SYS-044. The documentation requirements for software and cybersecurity are explained further in our YouTube video for v5.0 software documentation.
Software Description – A summary overview of the features and software operating environment.
Device Hazard Analysis – Tabular description of identified hardware and software hazards, including severity assessment and mitigations.
Software Requirement Specification (SRS) – This documents the software requirements about hardware requirements, programming language requirements, interface requirements, software performance, and functional requirements.
Architecture Design Chart – Detailed depiction of functional units and software modules. It may include state diagrams as well as flow charts.
Software Design Specification (SDS) – The SDS describes how the requirements in the SRS are implemented. The information presented in the SDS should be sufficient to ensure that the work performed by the software engineers who created the Software Device was clear and unambiguous, with minimal ad hoc design decisions. The SDS may reference other documents, such as detailed software specifications.
Traceability Analysis – Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing.
Software Development Environment Description – Summary of software life cycle development plan, including a summary of the configuration management and maintenance configuration activities.
Verification and Validation Documentation – Description of software verification and validation activities at the unit, integration, and system level. System-level test protocol, including pass/fail criteria and test results.
Revision Level History – Revision history log, including release version number and date.
Unresolved Anomalies (Bugs or Defects) – List of remaining software anomalies annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors.
Cybersecurity – The process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.
Our procedure for software validation (SYS-044) is available:
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.
Our electrical safety testing webinar is part of our 510k course series to help you learn how to prepare an FDA eSTAR for powered devices.
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Electrical Safety Testing Webinar ($79)
Electrical Safety Testing Webinar
In this webinar you will learn how to identify a testing lab, when to engage a testing lab, what documentation the testing lab will need, what additional standards are applicable beyond IEC 60601-1, and how to determine what is considered essential performance.
Price: $79.00
When is the Electrical Safety Testing Webinar?
This webinar will be live on Thursday, January 18, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as many times as you wish. If you already purchased our 510k course, you will automatically notified of the login information for this webinar via an AWeber email to subscribers of the 510k course. You will also be notified of future updates.
Why you should register for the Electrical Safety Testing Webinar
The testing requirements for 510k and De Novo submissions are based upon the most recently recognized standard for electrical safety. Still, the new FDA eSTAR asks the submitter to answer specific questions about the testing report and reference the pages where information can be found. In this electrical safety testing webinar, you will learn:
how to prepare for electrical safety testing
how to identify a testing lab
when to engage a testing lab
what documentation the testing lab will need
what additional standards are applicable beyond IEC 60601-1
how to determine what is considered essential performance
What you will receive
a recording of the webinar you can replay anytime
the native slide deck for this webinar
If you would like to ask specific questions about electrical safety testing, please submit them via email or schedule a call using the calendly app on our contact us page.All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the electrical safety testing webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email.You can also follow him on our YouTube channel,LinkedIn, or Twitter.
This is part one of a case study on how to perform a packaging complaint investigation when packaging is found open by a customer.
Overview of Packaging Complaint Investigation
This case study example involves a flexible, peelable pouch made of Tyvek and a clear plastic film. This is one of the most common types of packaging used for sterile medical devices. In parallel with the complaint investigation, containment measures and corrections are implemented immediately to prevent the complaint from becoming a more widespread problem. The investigation process utilizes a “Fishbone Diagram” to identify the root cause of the packaging malfunction. This is just one of several root cause analysis tools that you can use for complaint investigations, but it works particularly well for examples where something has gone wrong in production process controls, but we are not sure which process control has failed.
Description of the packaging malfunction
The first step of the complaint handling process (see SYS-018, Customer Feedback and Complaint Handling) is to record a description of the alleged quality issue. A distributor reported the incident that was reported. The distributor told customer service that two pouches in a box containing 24 sterile devices were found to have a seal that appeared to be delaminating. Unfortunately, the distributor was unable to provide a sample of the delaminated pouches or the lot number of the units. Packaging issues and labeling issues are typically two of the most common complaint categories for medical devices. Often the labeling issues are operator errors or a result of labeling mixups, while the packaging errors may be due to customers who accidentally ordered or opened the wrong size of the product. Therefore they may complain about packaging when there is nothing wrong. It is essential to be diligent in the investigation of each packaging complaint because if there is a legitimate packaging quality issue, then there may be a need for a product recall as part of your corrective action plan.
Initiation of the packaging complaint investigation
In your complaint record, you need to assign a person to investigate the complaint. The only acceptable reason for not initiating an investigation is when a similar incident was already investigated for another device in the same lot or a related lot (i.e., packaging raw material lot is the same and the problem is related to the material). If the complaint was already investigated, then the complaint record should cross-reference the previous complaint record.
The person assigned to investigate the complaint must be trained in complaint investigations and should be technically qualified to investigate the processes related to the complaint (e.g., packaging process validation). The investigator must record which records were reviewed as part of the investigation, and the investigation should be completed promptly in case regulatory reporting is required or remedial actions are needed. It is also necessary to demonstrate that complaints are processed in a consistent and timely manner (e.g., average days to complaint closure may be a quality objective).
Regulatory reporting of packaging failures
We know everyone wants to avoid regulatory reporting because we are afraid that other customers will lose confidence in our product and bad publicity may impact sales. However, the consequences of failing to file medical device reports with the FDA are much worse. Even if an injury or death did not occur with a sterile medical device, the quality issue should still be reported as an MDR under 21 CFR 803 (see SYS-029, Medical Device Reporting) because a repeat incident could cause an infection that could result in sepsis and death. If you think that this is an extremely conservative approach, you might be surprised to learn that 251 MDRs were reported to the FDA in Q4 of 2023 for packaging issues. Of these reports, only one involved an actual injury, and the other 250 involved a device malfunction but no death or injury. The following event description and manufacturer’s narrative is an example:
Event Description
“It was reported by the sales rep in japan that during an unspecified surgical procedure on (b)(6) 2023 the rgdloop adjustable stnd device sterile package was not sealed and was unclean.Another like device was used to complete the procedure.There was an unknown delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.”
Manufacturers Narrative
“This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.Udi: (b)(4).”
Packaging complaint investigation when product IS NOT returned
What the narrative above does not elaborate on is what was the specific investigation details for “lot history reviewed.” One of the most useful tools for performing a packaging complaint investigation is the “Fishbone Diagram.” Other names include, “Ishikawa Diagram” and “Cause and Effect Diagram.” There are six parts (i.e., “6Ms”) to the diagram:
materials,
method,
machine,
“mother nature” or environment,
“manpower” or people, and
measurement.
What records can be investigated without the return of the product?
The following records could be reviewed and evaluated for potential root causes even if the customer does not return the packaging with the alleged malfunction:
review the complaint log for other complaints with the same lot number and/or from a similar period, lot of raw materials, or packaging machine
review the device history record for the lot to make sure that the number of units rejected as part of normal in-process and final inspection did not exceed pre-established thresholds for monitoring the sealing process
if retains of the lot are available, these might be retested to verify that the testing results after real-time aging remain acceptable
the maintenance and calibration records of the equipment for manufacture and testing may be reviewed to verify that no repairs were required and no equipment was identified as out-of-calibration
If all of the above fail to identify a potential cause for a packaging failure, then you might have a problem related to people or the environment. People include the people sealing the product package and the users. The environment consists of the temperature and humidity for storage of packaging raw materials, packaged products, sterilization conditions, storage conditions after sterilization, and shipping conditions–including any temporary extremes that might occur during transit.
In our case study, the product was not returned, and we did not have the lot numbers. Therefore, we may need to review distribution records to that distributor and/or the customer to narrow down the possible lots to one or more lots. Then we would need to perform the same type of review of lot history records for each potential lot. The best approach is to request a photo of the package labeling, including the UDI bar code, because that information will facilitate lot identification. Even if the product was discarded, often the UDI will be scanned into the patient’s electronic medical record (EMR) during surgery.
Conducting investigations when product IS returned
Sometimes you are fortunate enough to receive returned products. The product should be immediately segregated from your other products to prevent mixups and/or contamination. Normally the returned products are identified as non-conforming products and quarantined. After the quarantined product is evaluated for safety, the assigned investigator may inspect the packaging in a segregated area. Packaging investigations begin with visual inspection following ASTM F1886. If multiple packaging samples are available, or the packaging is large enough, the investigator may destructively test (i.e., ASTM F88) a 1” strip cut from the packaging seal to verify that the returned packaging meets the original specifications. If you kept retains of packaging with the same lot of flexible packaging, you may visually inspect and destructively test retains as well.
Next steps of the packaging complaint investigation
Once the root cause is identified for a packaging complaint, then you need to implement corrective actions to prevent a recurrence. Also, FDA Clause 21 CFR 820.100 and ISO 13485, Clause 8.5.3, require that you implement preventive actions to detect situations that might result in a potential packaging failure in the future and implement preventive measures so that similar packaging failures are not able to occur. If you are interested in learning more about conducting a root cause analysis, please read our blog on this topic: Effective Root Cause Analysis – Learn 4 Tools.
This article is the first half of the packaging complaint investigation case study. The second half of the two-part case study explains the necessary containment measures, corrections, corrective actions, and preventive actions to address the root cause of the packaging failure.
Additional packaging validation resources
There are many articles on the topic of package testing and package design for sterile medical devices. If you want to learn more, please register for our free webinar on packaging validation by Jan Gates.
The complaint handling procedure and webinar will teach you how to process complaints and document them for regulatory reporting.
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When is the Complaint Handling Webinar?
The updated complaint handling procedure and webinar are now only available as a bundled digital product. The updated webinar was hosted live on January 4, 2023. A link to download a recording of the live training will be delivered by email after the live event to train other people in your company.
The complaint handling procedure was completely updated for compliance with the US FDA (21 CFR 820.198), ISO 13485:2016, Health Canada (SOR 98/282, Sections 57 & 58), and both of the European Regulations. The complaint record (i.e., FRM-020) was also completely re-written. Finally, this procedure bundle includes a training webinar on complaint handling to use for training of your complaint handling unit.
Price: $299.00
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
Complaint handling is one of the most common FDA 483 inspection observations. Therefore, we created this procedure and webinar bundle to help your complaint handling unit comply with 21 CFR 820.198 and ISO 13485:2016, Clause 8.2.2. This webinar was originally recorded as a free live webinar on October 4, 2015. The following items are included in this webinar bundle:
SYS-018 v0.3, Customer Feedback and Complaint Handling Procedure (Procedure in Word format)
LST-011 v0.1, Complaint Register (i.e., Complaint Log in Excel format)
FRM-020 v0.3, Complaint Record (Protected Form in Word format – no password)
a native slide deck for the webinar
a link to download the recording of the webinar
a quiz and training certificate
The procedure does not include regulatory reporting requirements that are found in our other related procedures:
This procedure is the primary document meeting the applicable regulatory requirements for gathering customer feedback and complaint handling as defined in your company’s Quality System Manual (POL-001).The revised and updated procedure is now six pages. The procedure define your company’s requirements for gathering customer feedback, documenting product complaints, and performing complaint investigations. The procedure is updated to include the requirements for the US FDA (21 CFR 820.198), ISO 13485:2016, Health Canada (SOR 98/282, Sections 57 & 58), and both of the European Regulations. Cross-references to each of these requirements was added to the procedure to demonstrate compliance and facilitate certification audits. Each reference is color coded and uses symbols that can be digitally searched (i.e., [CRTL+F]). The complaint record (i.e., FRM-020) was also completely re-written (now seven pages). The updated form now includes 100% of the requirements in the US FDA’s MedWatch Form 3500A. This ensures that complaint records include all the information that is needed for regulatory reporting if you determine that reporting is required.
In this article, you will learn how to hire an auditor to conduct medical device internal audits and supplier audits.
Stop begging people to help you audit. Learn how to recruit auditors more effectively.
Hiring and Auditor
Hiring an auditor, whether as a consultant or a permanent team member, is a critical decision that can drastically improve your quality management system and foster a culture of quality, or it can add no value and lead to disruption and frustration. The purpose of this blog is to identify the qualities and training that make the best auditor to help you elevate your internal audit programs.
Audit Program Structures
Companies typically take one of the following approaches to address their internal audit requirements:
Train internal personnel with other primary functions as auditors and have them audit other departments.
Hire an independent 3rd party to conduct the internal audits.
Build an internal audit team that is independent of all other processes.
Hiring an Auditor from Within
Option 1 is common across the industry and is a personnel-efficient means of achieving the audit objectives. While this type of approach can sometimes be effective and may satisfy the basic requirement to conduct internal audits, there can be some drawbacks to this structure. Sometimes, when people were not hired specifically to be auditors and auditing is something they were asked to do in addition to their regular job, there is little to no motivation to develop auditing skills, and the audits lack a depth and thoroughness that ultimately reduces the value of the audit program. Proper internal recruiting and training of these auditors is crucial to ensuring audits are a useful value-added exercise and not a box-checking chore.
To successfully recruit internal auditors serving in other roles, it’s important to motivate people to want to be an auditor. Let potential recruits know that employees with audit experience are more valuable to companies than those without. It exposes employees to upstream or downstream processes to better understand the overall operations and provides them the opportunity to make process improvements in both directions to their workflow. If you want to be effective and get promoted, you need to demonstrate value to your boss and top management. If you don’t understand what other departments need, how can you help them? No manager will promote a selfish, power-hungry hog. They promote team players that make others better. Auditing gives you the insight necessary to understand how you can do that.
Once motivated and recruited, it’s important to ensure these employees have the skills and resources to be successful as auditors. To help develop their skills, training on audit processes and the responsibilities and role of an auditor in accordance with ISO 19011 will provide guidance on conducting audits and the basics of how to audit. Auditors should also be trained against the specific standard or regulation they are auditing against, which may include ISO 13485, 21 CFR 820, ISO 14971, EU MDR, and others. Resources that will support their activities may include process audit diagrams, checklists, examples of record requests, strategies for intelligent sample selection, and, of course, a clear definition of the regulatory and procedural requirements of the process that they are auditing.
If you are looking for support in training your own employees to be internal auditors, we would be happy to outline or provide a training program specific to your company’s processes and products to ensure your auditors are competent and effective in their new role.
Hiring a 3rd Party Auditor
Option 2 can be useful to any company, but selecting the right auditor is essential to the success of this approach. The basic qualifications and qualities that I recommend companies look for when hiring an outside auditor are:
Experience – this includes industry experience and regulatory knowledge. An auditor with experience auditing or working for a company with similar devices, manufacturing processes, etc., will provide more value than an unfamiliar auditor. Regulatory knowledge and experience within your targeted markets are also important to evaluate to ensure that they are familiar with the standards and regulations against which they will be auditing.
Communication Skills – This is a make-or-break quality of auditors that can shift the substance of an audit from a value-added exercise to a disrupting and frustrating experience. You want to ensure that auditors are affable yet confident, able to communicate the usefulness of the audit for the purpose of process improvement and facilitate a productive dialogue, offering education and suggestions when issues or nonconformances arise.
Reputation and References – ask the auditor for references from previous clients. Contact the references to get feedback on their performance, reliability, and professionalism. This is a great way to evaluate an auditor’s communication skills and whether previous auditees gained value from the interaction.
Auditor Training – acceptable qualifications for an auditor can be defined by the company but may include lead auditor certification, demonstrated training on relevant standards with experience shadowing experienced auditors, and documented training on other relevant standards/regulations.
Audit Methodology – Inquire about how auditors plan, execute, and report on audits. What audit methodology does the auditor prefer for the scope of your audit, and why?
There are many companies and consultants that offer 3rd party auditor services, but not all are created equal. Like the CAPA process, the internal audit program is a window into the culture surrounding quality that your company has, and by demonstrating that you are proactively policing yourself and seeing continuous improvement through an effective internal audit program will show regulators that your company has a commitment to quality.
Hiring a Full-time Audit Team
Option 3 is generally reserved for the resource-rich industry with operations that demand expansive continuous audit processes to justify the support of a full-time auditor or audit team. Hiring your own team benefits from the same considerations that come with hiring a 3rd party auditor; the ability for the auditors to become intimately familiar with the company, devices, and processes is valuable. For companies that do not have the need for full-time auditors, the same value of familiarity can come from building a trusted relationship with a third-party auditor or audit team, who can support your audit program year after year.
Hiring an Auditor from Medical Device Academy
Our goal at Medical Device Academy is to help you improve your quality system and provide valuable consulting advice to achieve improvements. We specialize in helping start-up companies achieve initial ISO 13485 certification, MDSAP certification, and CE Certification. Based on the scope of the audit and medical device, we will assign the most qualified team member. Some of our specific areas of expertise include auditing companies with manufacturing and machining, aseptic processing, agile software development, sterile products, medical device reprocessors, 3D printed manufacturing, and more. If you are interested in outsourcing any supplier or internal audit activities, you can check out our Audit Services page to get in touch or to learn more about our audit team.
This predicate selection webinar explains the step-by-step process for conducting predicate selection as part of your 510k submission.
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Please submit comments to the FDA regarding the new FDA draft guidance on best practices for predicate selection
On September 13, 2023, we prepared a blog discussing the new FDA draft guidance for predicate selection best practices. We have specific recommendations for changes to this draft guidance. We want to encourage others to voice their opinions as well. We published our redlined draft and it is available for download using the blue button below. If you would like to view the original click the green button. The FDA has a webpage with tips on how to respond to the guidance with comments and feedback. The deadline for submission of comments was December 6, 2023 @ 11:59 pm ET.
What is included in the 510k predicate selection webinar?
September 20, 2023, we are hosting a live and updated version of our predicate selection webinar (recording will be available afterward). This is one of the many webinars that comprise our 510k Course that is available as a bundle for sale. The webinar now includes updated elements from the new FDA draft predicate selection guidance. The expected duration of the webinar is just over 1 hour. There were 28 slides in the updated presentation, and we will demonstrate how to use the following FDA databases:
A new software tool will be demonstrated as another method of searching for potential predicate devices instead of relying only upon the FDA database. That software tool is licensed from Basil Systems, and the ability of the software to automatically create a “predicate tree” and provide quick access to all of the potential 510k summaries within a product classification is impressive. We will cover strategic considerations when selecting a predicate device for your 510k submission. We will demonstrate how to enter your predicate selection into the new FDA eSTAR templates, and we will identify all of the locations in a 510k submission where your chosen predicate is referenced. If you are unable to identify a suitable predicate selection for your 510k submission, then you have five options.
What is a predicate device?
The premise behind the FDA 510k regulation is that your new device is substantially equivalent to another device (i.e., a predicate device) that is already on the market. Therefore, you only need to submit a premarket notification to the FDA instead of a premarket approval (PMA) submission. Most 510k submissions reference a similar device manufactured by a competitor, and as long as your device is similar to the predicate device, the matter of predicate selection is given little additional thought. There may only be one predicate device to choose from, or there may be hundreds of potential predicate devices.
510k Predicate Selection Webinar – $64.50
510(k) Predicate Selection Webinar
September 20, 2023, we are hosting a live and updated version of our predicate selection webinar (recording will be available afterward). This is one of the 58+ webinars that comprise our 510k Course that is available as a bundle for sale. The webinar now includes updated elements from the new FDA draft predicate selection guidance. The expected duration of the webinar is just over 1 hour. There were 28 slides in the updated presentation
Price: $64.50
If you purchase one or more of the 510k course webinars and you decide to upgrade to the full course, we will issue a credit for previous purchases toward the 510k course. Please contact Rob Packard or Becca Taylor by email with a list of your previous purchases in the bundled course.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email.You can also follow him on YouTube,LinkedIn, or Twitter.
