Search Results for: 13485

This webinar teaches you how to create a Risk Mitigation Table systematically for your FDA De Novo submission. 

Creating a risk mitigation table for a De Novo submission Webinar ($49)

How to create a risk mitigation table to include with your De Novo submission Webinar

This webinar teaches you how to create a risk mitigation table systematically. The webinar includes multiple examples, and participants will receive a copy of our De Novo template for a risk mitigation table. This webinar is also included in our 510(k) Course.

Price: $49.00

When is the risk mitigation table webinar?

This webinar will be live on Thursday, June 27, 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.

What you will receive:

The webinar is included in our 510(k) course. The webinar includes:

• risk mitigation table template (with prefilled examples)
• multiple examples from other De Novo submissions
• native slide deck
• link to download the recording
• login information (if purchased before June 27, 2024)

If you would like to ask specific questions about preparing your test plan, please submit them via email or schedule a call using the calendar 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.

Additional Resources for 510k submissions

If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 513(g) Classification Requests, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of this webinar.

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 identification and traceability procedure meets two requirements in ISO 13485:2016 (i.e., Clause 7.5.8 and Clause 7.5.9).

Identification and Traceability Procedure (SYS-032) and Webinar Bundle

SYS-032 Identification & Traceability Procedure

SYS-032 Identification & Traceability Procedure

Price: $299.00

What you will receive

• SYS-032 A D5 Identification and Traceability

If you would like to ask specific questions about the Identification and Traceability Procedure (SYS-032), please submit them via email or schedule a call using the calendar app on our contact us page. All content deliveries will be sent via AWeber emails to confirmed subscribers. Please check your spam folder if you don’t receive the content automatically.

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. 

 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

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.

In this webinar, you will learn how to prepare a verification and validation test plan for your 510(k) or De Novo submission. 

Test Plan Webinar ($79)

Test Plan Webinar

In this webinar, you will learn how to prepare a test plan for your 510(k) or De Novo submission. You will receive a copy of Medical Device Academy's test plan template. You will learn how to determine which parts of the template are applicable and which parts are not applicable. You will also learn how to perform six different cross-references to make sure the testing plan is complete.

Price: $79.00

When is the Test Plan Webinar Webinar?

This webinar will be live on Thursday, February 22, 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 Test Plan Webinar

You will learn how to determine which parts of the template are applicable and which parts are not applicable. You will also learn how to perform six different cross-references to make sure the testing plan is complete.

What you will receive

• an invitation to participate in the live webinar (if you purchase prior to February 22)
• a recording of the webinar you can replay anytime
• the native slide deck for this webinar
• a copy of the test plan template

If you would like to ask specific questions about preparing your test plan, please submit them via email or schedule a call using the calendar 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.

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.

This work instruction provides detailed instructions for a security incident response to a cybersecurity incident.

Security Incident Response Planning (WI-008) & Webinar Bundle

WI-008 Security Incident Response

This work instruction provides detailed instructions for responding to cybersecurity incidents. The work instruction utilizes Medical Device Academy's CAPA report form (FRM-009) and we provide a form for reporting security incident investigations (FRM-059). The procedure is in compliance with the 2023 Guidance from the FDA on cybersecurity of device pre-market submissions.

Price: $299.00

This work instruction provides detailed instructions for a security incident response to a cybersecurity incident. The work instruction utilizes Medical Device Academy’s CAPA report form (FRM-009). Each section of the CAPA report form is filled in to provide guidance on the information that should be entered in the CAPA report form for a security incident response plan. The procedure complies with the 2023 Guidance from the FDA on the cybersecurity of device pre-market submissions.

When is the webinar about this security incident response work instruction?

This webinar was recorded on Saturday, April 6, 2024. You can purchase it on-demand and watch the training as often as you wish.

What you will receive:

A template for a service record and a service log are included with the procedure. FRM-008 is also included with this procedure because when a product is returned for service, it should be treated as non-conforming material and segregated from the released product. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:

• WI-008 Security Incident Response
• FRM-059, Security Incident Investigation Report
• FRM-009, CAPA Report (for Security Incidence Response)
• Native Slide Deck for Training Webinar (22 slides)
• Recording of Training Webinar (April 6, 2024; 39 minutes)

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. 

This procedure utilizes Medical Device Academy’s CAPA form. Please visit our CAPA procedure webpage for more information. This procedure also references our cybersecurity work instruction (WI-007).

About the Speaker

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. Robert was a senior manager at several medical device companies—including 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 certification. 2009-2012, 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. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube, LinkedIn or Twitter.

 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

This webinar will explain how to properly complete a use specification as the first step in building your usability engineering file.

Use Specification Template & Webinar Bundle ($79)

Use Specification Template & Webinar Bundle

This webinar reviews Medical Device Academy's Use Specification Template in detail. The webinar also explains the differences between the requirements for a Use Specification in IEC 62366-1 and the corresponding FDA requirement for a description of device users, use environments, and user interfaces.

Price: $79.00

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After verifying the transaction, please check your email for the download (including your spam folder). 

When is the Use Specification Webinar?

This webinar was hosted live on Thursday, September 12, 2024 @ 10:30 a.m. ET. If you were unavailable for the live presentation, the session was recorded. You can download the recording and watch the training as often as you wish.

What you will receive

• Use Specification Template
• Access to download the recording of the webinar from our Dropbox folder
• Native slide deck for this webinar
• FDA Guidance on Human Factors

There are 34 slides in the presentation, and the presentation was 51 minutes in duration. All content deliveries will be sent via AWeber emails to confirmed subscribers.

What is the difference between the IEC 62366-1 and FDA requirements?

The FDA requirements for a description of the device-user system is a sub-set of the requirements for a use specification as defined in IEC 62366-1, Clause 5.1. Therefore, if you create a use specification that complies with IEC 62366-1, then this document can be submitted to the FDA instead of creating a separate description of the device-user system. The only unique element of use specification requirement is the “operating principle.” There are other minor differences between the two documentation requirements, but those differences are specific to the IEC 62366-1 definition of individual elements in the use specification (which will be described in detail during the training webinar).

Why do regulators need a use specification?

To properly assess use-related risks for devices, you first need to understand the intended users, the intended patient population, the use environment, and the device-user interfaces. Ideally, all of this information is included in your Instructions for Use (IFU) and your device description. IEC 62366-1, Clause 5.1, requires that manufacturers create a use specification as the first required elements of your usability engineering file (UEF).

Our General Approach

You should start your human factors process by defining the intended user of your device and by defining if there is more than one user group. In our device description template we have subsections that identify the intended users, the intended patient population, and the environment of use. Each of these sections is near the beginning of our device description template, immediately after the indications for use. Later in the device description template, the are subsections looking for pictures of the functional elements of your device. These pictures should include any elements that are part of the device-user interface. If you properly fill in the device description template with these details, creating a use specification is trivial, because you only need to copy and paste the information from your device description into the use specification. The only remaining element of a use specification that is not found in a description of the device-user system is the “operating principle.” Our device description includes a section titled “principles of operation” that can be copied to meet this required.

What will happen if you forget to include this information in your submission?

If you forget to include a use specification in your usability engineering file (UEF), this will be identified as a deficiency by certification bodies and electrical safety testing labs. In addition, the FDA requires a description of your device-user system in your 510(k) submission, and you will receive a deficiency if this is not identified. In fact, reviewers may refuse to review the rest of the human factors documentation if this basic information is omitted from a pre-sub questions about human factors or your pre-market submission.

Other Usability Engineering / Human Factors Training

• Formative Usability Testing Webinar & Template Bundle – $79
• Use Error and Abnormal Use Decision Tree Training – $79
• Known Use Errors Search Webinar – $129
• Task Analysis Template & Webinar Bundle – $129 – Live Webinar, October 17, 2024
• Use-Related Risk Analysis (URRA) Template & Webinar Bundle – $299
• Participant Screening & Data Collection Forms – $79 – November 27, 2024
• Summative Usability Testing Protocol & Webinar Bundle – $199 – Live Webinar, December 19, 2024
• Summative Usability Testing Report – Live-streaming Free Webinar, December 20, 2024

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 YouTube, LinkedIn, or Twitter.

This webinar explains the differences between Traditional and Special 510k submissions and shows how they impact the FDA eSTAR.

Special 510(k) Webinar ($79)

Special 510(k) Webinar

This webinar explains the differences between a Traditional 510(k) submission and a Special 510(k) submission. This webinar includes details of how the completion of the FDA eSTAR is different for a Special 510(k) as well as the differences in what documentation is required for a Special 510(k) submission.

Price: $79.00

When is the Special 510k Webinar

This webinar was live on Thursday, March 28, 2024. The session will also be recorded. You can purchase it on-demand and watch the training as many times as you wish.

Contents of Special 510k Webinar

Registrants will receive a confirmation email, and then after confirmation, they will receive login information for the live Medical Device Academy webinar by Rob Packard. This webinar is included with our 510k Course series. It was originally a free webinar but is now a paid webinar with updated content specific to the FDA eSTAR template. The purchase of this webinar includes the following contents:

• an invitation to participate in the live webinar (if you purchase before March 28)
• a recording of the webinar you can replay anytime
• the native slide deck for this webinar
• a copy of the FDA guidance for Special 510k submissions
• templates created by our team that are specific to a Special 510k

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. Robert was a senior manager at several medical device companies—including 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 certification. 2009-2012, 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. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube, LinkedIn or Twitter.

In our new distribution procedure webinar you will learn how to maintain product distribution records in case of a potential recall.

Distribution Procedure (SYS-015) Webinar Bundle

SYS-015 Packaging, Handling, Storage, Shipping & Distribution

SYS-015 Packaging, Handling, Storage, Shipping & Distribution

Price: $299.00

When is the webinar about this distribution procedure?

This webinar will be live on Monday, April 1, 2024, at 10:30 a.m. ET. It will also be recorded. You can purchase it on-demand and watch the training as often as you wish.

What you will receive:

A template for a service record and a service log are included with the procedure. FRM-008 is also included with this procedure because when a product is returned for service, it should be treated as non-conforming material and segregated from the released product. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:

• SYS-015, Distribution Procedure
• LST-015, Distribution Log
• Native Slide Deck for Training Webinar
• Recording of Training Webinar (April 1, 2024)

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. 

About the Speaker

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. Robert was a senior manager at several medical device companies—including 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 certification. 2009-2012, 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. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube, LinkedIn or Twitter.

 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

The video provided below shows you exactly what you will receive when you purchase our Software Validation Procedure (SYS-044).

The Software Development and Validation procedure aims to define the documentation requirements and the process for product software development and validation within the Company’s quality management system. The procedure is appropriate for companies developing software as a medical device (SaMD) and software in a medical device (SiMD).

SYS-044 - Software Development and Validation Procedure

SYS-044 Software Development and Validation Procedure; This procedure is intended to meet the requirements of ISO 13485:2016, Clause 7.3.6 and 7.3.7 for design verification and design validation of medical device products. This procedure is also intended to meet the requirements of IEC 62304, ed. 1.1 and 21 CFR 820.30(a)(2)(i) and (g). Finally, the procedure is updated to reflect the requirements of the 2023 FDA guidance for pre-market submission content.

Price: $399.00

Does the software validation procedure meet the most recent requirements?

This procedure is intended to meet the requirements of ISO 13485:2016, Clause 7.3.6 and 7.3.7 for design verification and design validation of medical device products. This procedure is also intended to meet the requirements of IEC 62304 and 21 CFR 820.30(a)(2)(i) and (g). The procedure content has also been updated to comply with the 2023 FDA guidance for software documentation in pre-market submissions. The 2023 guidance requires that companies document the software risk documentation level as basic or enhanced. TMP-019 can be used to document this and attached to the eSTAR in the section shown in the screen capture below:

The FDA eSTAR also requires that companies attach nine different types of software validation documentation, as shown in the screen capture below:

One of the less obvious changes in the requirements is a requirement for submission of a software risk management file. instead of providing only a software hazard analysis:

1. A risk management plan,
2. Risk assessment (hazard analysis), and
3. Risk management report.

Does this software validation procedure include quality system software?

This procedure does not apply to the requirement for quality system software validation in ISO 13485:2016, Clause 4.1.6, validation of software for automated equipment in Clause 6.3 and 7.5.6, or validation of software used for monitoring and measuring calibrated equipment and devices in Clause 7.6. Those requirements are covered in SYS-014 Process Validation procedure, and the applicable technical standard is ISO 80002-2:2017.

This is the primary document meeting the applicable regulatory requirements for software development and validation as defined in the Quality System Manual (POL-001).

What is included with the purchase of this procedure?

The following is a list of documents included:

• SYS-044 A, Software Development and Validation
• TMP-009 Software Development Plan Template
• TMP-010 Software Requirements Specification Template
• TMP-011 Software Traceability Matrix Template
• TMP-012 Software Architecture Specification Template
• TMP-013 Software Design Specification Template
• TMP-014 Software Revision Level History Template
• TMP-017 Software Development Environment Description Template
• TMP-018 Software Description Template
• TMP-019 Documentation Level Evaluation Template
• TMP-020 Software Risk Management Plan (RMP)
• TMP-025 Verification Protocol Template
• TMP-026 Verification Report Template
• Native Slide Deck for Software Validation Webinar (March 7, 2024)
• Recording of Software Validation Webinar (March 7, 2024)

In addition to the procedures and templates, we have also created a zip folder with all four of the FDA guidance documents for software submissions:

• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices
• Guidance for Industry and Food and Drug Administration Staff Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
• Guidance for Industry, FDA Reviewers, and Compliance on Postmarket Management of Cybersecurity in Medical Devices

You also need to purchase a copy of IEC 62304:2006 from your favorite standards issuer.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. To view all available procedures, click here.

About the Author

Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Management Systems, Technical/Medical Writing, and is a Lead Auditor. Matthew has updated all of our procedures for  He is currently a student in Champlain College’s Cyber Forensics and Digital Investigations program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College. He can be reached by email. You can also follow him on LinkedIn or YouTube.

Purchase of this bundle will enable you to quickly update your clinical evaluation procedure and train employees to MEDDEV 2.7/1 rev 4.

Is this Clinical Evaluation Procedure updated to the EU MDR (i.e., Regulation 2017/745)?

As stated in the video above, we are in the process of updating the procedure to include references to the newest guidance documents from the MDCG:

• MDCG 2020-13 – Clinical evaluation assessment report template
• MDCG 2020-6 – Guidance on sufficient clinical evidence for legacy devices
• MDCG 2020-5 – Guidance on clinical evaluation – Equivalence

We are adding more detailed references to Article 61 and Annex XIV, Part A. Despite the changes, the process still follows MEDDEV 2.7/1 rev 4. Edits will be completed sometime in January 2024. As always, procedure updates are free for anyone who purchased a prior version.

Clinical Evaluation Procedure and Webinar Bundle available for $299.00:

SYS-041 - Clinical Evaluation Procedure and Webinar Bundle

This procedure and webinar bundle includes requirements for European MDR (Regulation 2017/745) and MDCG guidance documents.

Price: $299.00

 Typically, webinars are sold on our website for $129, and procedures are sold for $299. This bundle is sold for $299. As always, you receive a copy of the native slide deck and a link for downloading the recording.

Important Note: If you have already purchased the previous version of this procedure, you will receive the procedure update and webinar bundle at no charge.

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.

1. Clinical Evaluation Procedure 

Purpose – The purpose of this procedure is to define the process for performing a clinical evaluation following MEDDEV 2.7/1 rev 4.

Scope – This is the primary document meeting the applicable regulatory requirements for Clinical Evaluations as defined in the Quality System Manual (POL-001). Generally, this requires including the following elements in your Technical File (SYS-025) following Article 61 and Annex XIV Part A of the EU MDR:

• Clinical Evaluation Report
• Updates to the Clinical Evaluation Report
• Clinical Evaluation Plan

Consultants providing services approved by the company may rely on their procedure(s) instead of this procedure. Qualification and evaluation of a consultant is controlled by the Supplier Quality Management Procedure (SYS-011)…

2. Literature Search Protocol (TMP-004)

Blog on Clinical Evaluations

In June of 2017, the fourth revision of the guidance document for clinical evaluations was released. An overview of the updated guidance document can be found in the Medical Device Academy Blog by clicking here.

What will you receive when you purchase this bundle?

Anyone who purchases the clinical evaluation procedure and webinar bundle will receive an automated email via AWeber that includes an invitation to the live webinar and a link to the Dropbox folder with the following files:

• Updated version of the Clinical Evaluation Procedure (SYS-041)
• The associated literature search protocol template
• Native Slide Deck for the Webinar
• Recording of the Webinar

You will also receive access to any future updates to the procedure.

When is the webinar for the Clinical Evaluation Procedure?

The purpose of this procedure is to define the requirements for conducting receiving inspection of finished devices, sub-assemblies and components.

Receiving Inspection Procedure (SYS-033) and webinar bundle

SYS-033 - Receiving Inspection Procedure

The receiving inspection procedure bundle includes the receiving inspection procedure (SYS-033), the receiving inspection log (LST-004), and the nonconformity report (FRM-008). This procedure is also bundled with a webinar that explains the process and provides best practices. The procedure is used in conjunction with SYS-011 for Supplier Quality Management and SYS-023 for Control of Nonconforming Materials that are sold separately.

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 (including your spam folder). 

When is the webinar about the receiving inspection procedure?

This webinar will be live on Monday, February 26, 2024 @ 10:30 am ET. The session will be recorded. You can purchase it on-demand and watch the training as often as you wish.

What will you receive?

This four-page procedure is the primary document meeting the applicable regulatory requirements for conducting receiving inspection as defined in the Quality System Manual (POL-001). The procedure is updated for compliance with ISO 13485:2016 (Clause 7.4.3), 21 CFR 820.80, and Regulation (EU) 2017/745 for CE Marking. The following documents are included with this procedure:

• SYS-033 Receiving Inspection Procedure
• LST-004 Receiving Inspection Log
• FRM-008 Nonconformity Report (NCR)
• Invitation to participate in the live webinar if you purchase this before February 26
• Access to download the recording of the live webinar from our Dropbox folder
• Native slide deck for the webinar

The procedure includes details for inspections performed by your company, as well as inspections performed by your suppliers. The procedure also includes suggestions for a statistical sampling plan. Along with the procedure, you will also receive a template for receiving inspection log. You will need to create an inspection plan or work instructions for specific products if your component drawings and specifications do not include inspection requirements already.

To view all available procedures click here

To review a sample Medical Device Academy procedure click below: