Search Results for: 13485

The IVD 510k webinar gives you the basics of preparing a 510k submission for the FDA and explains key differences between an IVD and a non-IVD 510k.

Why you should register for the IVD 510k Webinar

Eighty percent of an IVD 510k submission is the same as a 510k submission for non-IVD medical devices. Many regulatory experts with only non-IVD experience are afraid to tackle their first IVD 510k submission, but the sections and documents that are unique to IVD products are easy to learn. This webinar explains how to find IVD predicates and how to write an IVD device description. Most important of all, you learn how to plan for the differences in performance testing requirements.

What you will receive for $29

• access to the live webinar (new Zoom platform)
• a recording of the webinar you can replay anytime (mp4 format)
• the most recent version of the device description template for IVD products (Word doc)
• the native slide deck for this webinar (PPT format)

There will be 25-35 slides during the presentation. The presentation will be 45-50 minutes in duration, and you will have the opportunity to ask questions during the live webinar. Content will be sent via AWeber emails to confirmed subscribers.

IVD 510k Webinar ($29)

510(k) Submission for IVD Product

In this webinar you will learn the basics of preparing a 510k submission specifically for an in vitro diagnostic (IVD) product.

Price: $29.00

When is the IVD 510k Webinar?

On Friday, March 17 we will be hosting the IVD 510k Webinar live at 10:00 am EDT.

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 Google+, LinkedIn, or Twitter.

In this webinar, you will learn how to create an Executive Summary for your 510k submission and how complete an RTA Checklist to ensure your 510k Submission is ready.

Why you should register for the Executive Summary Webinar

In this webinar, you will learn exactly how to prepare your Executive Summary in minutes using a template and by copying and pasting content from other sections of your submission. I will review the guidance from the FDA as well as provide information from three other 510k submissions for a variety of device types. The webinar also reviews how to complete each section of an RTA Checklist.

What you will receive for $79

• a recording of the webinar you can replay anytime
• the most recent version of my templates for the Executive Summary and the FDA RTA Checklist
• the native slide deck for this webinar

There are 22 slides in this presentation. The is 33 minutes in duration.

Executive Summary Webinar $79

Executive Summary & RTA Checklist Webinar

In this webinar you will learn how to create an Executive Summary for your 510k submission and how complete an RTA Checklist to ensure your 510k Submission is ready.

Price: $79.00

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 Google+, LinkedIn, or Twitter.

FDA eSTAR will automatically generate a 510k summary. Should you use that feature or create a 510k statement instead?

510k Summary Webinar ($79)

510k Summary Webinar

In this webinar you will learn how to create a 510k summary for your 510k submission and how to decide if you should use a 510k Statement Instead.

Price: $79.00

When is the 510k Summary Webinar?

This webinar was live on Thursday, January 11. 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 510k Summary Webinar

The format and content requirements for a 510k summary have not changed, but the FDA eSTAR now allows you to generate a 510k summary automatically. You will learn where the FDA eSTAR is collecting information from in order to generate the summary automatically. We will review the guidance from the FDA and provide an analysis of multiple 510(k) summaries for a variety of device types. We will also discuss when it makes sense to use a 510k statement and how to create your own 510k summary using our template.

What you will receive

• a recording of the webinar you can replay anytime
• the most recent version of my templates for a 510k Summary and a 510k Statement
• the native slide deck for this webinar

There are 34 slides in the presentation. The presentation was 47 minutes in duration. If you would like to ask specific questions about preparing a 510k Summary or Statement, 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.

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 Google+, LinkedIn, or Twitter.

In this FDA eCopy webinar, you will learn the tips for preparing your eCopy submission of a 510k or pre-submission meeting request.

The FDA eCopy webinar and our 510(k) Cover Letter template have been updated to reflect the new FDA eCopy guidance requirements released on December 16, 2019.

Temporary Reduction of eCopy Fee to Help Anyone Under COVID-19 Quarantine

Some of our customers, and one of our employees, are subject to stay-at-home orders. In some countries, quarantine is nationwide. Medical Device Academy’s office is in a rural area of Vermont and we should be able to continue deliveries to the local FedEx office for quite a while–if not indefinitely. For now, the FDA is still accepting shipments to the document center (but we will let everyone know when and if that changes).

July 2022 Update for the FDA eCopy process

The FDA created a Customer Collaboration Portal (CCP) for medical device manufacturers. Originally, the portal’s purpose was to provide a place where submitters can track the status of their submissions and verify the deadlines for each stage of the submission review process. Last week, on July 19, the FDA emailed all active FDA CPP account holders that they can upload both FDA eCopy and FDA eSTAR files to the portal 100% electronically. Since our consulting team sends out submissions daily, everyone on the team was able to test the new process. If you have a CCP account, you no longer need to ship submissions via FedEx to the Document Control Center (DCC).

Due to the elimination of shipping via FedEx, elimination of USB flash drives, and elimination of printing the cover letter, the pricing of our FDA eCopy service is reduced to $79. If you want us to complete an NDA, please don’t hesitate to send your NDA to me at rob@13485cert.com. The business is an Indiana Corporation with a principal office address located at Medical  Device Academy, Inc. 345 Lincoln Hill Rd., Shrewsbury, VT 05738 USA. I can also send you a free template for your eCopy cover letter if you need one.

When is the FDA Webinar?

The original FDA eCopy webinar was recorded on November 10, 2016, shortly after the FDA eCopy service was launched. We presented an updated webinar about eCopies on Wednesday, August 30, 2017. Over time, the FDA made additional changes to their policy, and new guidance was released on December 16, 2019, and we recorded a new webinar on December 27, 2019. It’s free to register for the FDA eCopy webinar as long as you ask a question. As new questions are submitted, we will add the questions to our 510k FAQs page.

Contents of the Webinar

On August 22, 2016, we published a blog posting that is a great example of the kind of information you will learn in the FDA eCopy webinar. Registrants will receive a link to download a recording of the webinar and the native slide deck. You will also receive a copy of the new FDA eCopy guidance and our cover letter template for eCopies. Additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page. You can also read our new blog explaining the changes in the new eCopy guidance.

If you are almost done with preparing your 510k submission or a pre-submission meeting request, you can save yourself some time and prevent mistakes by hiring us to prepare, validate, print, and ship your FDA eCopy. In October 2016, the FDA eCopy service was launched, and the first customers hired us to help them print and ship their FDA submissions.

Updated 2019 Pricing of Our Services

At the beginning of 2018, the FDA announced an unofficial change to the eCopy submission policy. The FDA no longer requires the complete paper submission. Instead, you can submit an eCopy accompanied by a paper copy of the signed cover letter. The new 2019 eCopy guidance documents this policy, which is now official.

The FDA eCopy is required for 510k submissions, pre-submission requests, q-sub meeting minutes and De Novo applications. These submissions vary in size from < 50 pages to greater than 6,000 pages. Pre-submission requests and meeting minutes from a q-sub meeting are generally < 100 pages.

To Purchase FDA eCopy Services Now

Please assemble your submission in compliance with the eCopy  guidance requirements, and share the eCopy with us using one of four methods:

1. Email the files to rob@13485cert.com (only for non-volume-based submissions that are less than 10 MB in total).
2. Create a zip folder with your folders and/or files, and send them to rob@13485cert.com using the free WeTransfer service (only for submissions less than 2 MB).
3. Upload the folders and/or files to Dropbox and share with rob@134585cert.com. I can also share a folder I create with you, and then you can upload the content.
   
4. Upload the folders and/or files to Google 1, formerly Google Drive, and share with red66climb@gmail.com.

FDA eCopy for pre-submission requests, 510(k) Submission, De Novo Application or Supplements

Pricing is now reduced to $79, because we can now use the FDA Customer Collaboration Portal (CCP) to submit 100% electronically. This price includes the cost of validating you eCopy and uploading to the CCP. This can be used for any eCopy for the DCC.

Price: $79.00

If you have a PDF report from a testing lab that has a file size that is more than 50MB, you will need to split the file into multiple files. If you have non-PDF files that need to be included (e.g., Excel spreadsheets or videos), you will need to place the files in a “MISC FILES” or “STATISTICAL DATA” folder. If you need any help with creating your FDA eCopy, please contact us. There is no additional charge for < 15 minutes of our assistance. If you need urgent help to meet a deadline, please text Rob Packard @ +1.802.258.1881.

If you need more help, our hourly consulting rate is provided on the Standard Pricing Sheet. We can review your submission for potential corrections or improvements needed. We can complete an RTA checklist for you to ensure that there are no obvious missing elements that would result in your submission being rejected during the RTA screening, we can help you convert files to PDF documents, and we can help you address any deficiencies already identified by the FDA before re-submission.

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 Google+, LinkedIn, or Twitter.

In this webinar, you will learn how to use the new Redacted FOIA 510k Database on the FDA website in order to find more information about testing that was performed for potential predicate devices.

Why you should register for the Redacted FOIA 510k Webinar

For years I have been trying to identify what testing data was provided by other manufacturers in their 510k submission so that I can advise my clients regarding which predicate to select for a 510k submission. The four sources of information I used (until this week) were:

1. the 510k Summary
2. the product classification webpage
3. special controls guidance documents
4. recognized standards related to the device

There are two other sources that I used:

1. redacted 510k submissions requested as per 21 CFR 807.93 (i.e., 510k Statements)
2. redacted 510k submissions requested through the Freedom of Information Act (i.e., FOIA)

In the past, my primary method of obtaining more information was to request redacted 510k submissions directly from companies that had submitted a 510k Statement instead of a 510k Summary. These companies are required to provide a copy within 30 days. Recently the FDA made redacted 510k submissions that have already been requested available on the FDA website. Therefore, this is now my primary method of learning information about potential predicates.

In this webinar, I will teach you how to get the most out of this new online database, and how to build your own 510k library of devices marketed by your competitors. These competitor 510k submissions are redacted, but you can still learn a lot more from the redacted submissions than you could from a 510k summary.

If there is a specific 510k submission that you want to review and the 510k is not currently available online, you can also submit a FOIA request online. I review this process during the webinar and I provide a template for submitting FOIA requests. The application process takes less than 5 minutes.

What you will receive for $79

• a recording of the webinar you can replay anytime
• the most recent version of my FOIA request form template
• the native slide deck for this webinar

There are 29 slides during the presentation. The presentation is 48 minutes in duration–including the Q&A session from the live presentation. All deliveries of content will be sent via AWeber emails to confirmed subscribers.

Redacted FOIA 510k Webinar – $79

Redacted FOIA 510k Webinar

In this webinar you will learn how to use the new Redacted FOIA 510k Database on the FDA website in order to find more information about testing that was performed for potential predicate devices.

Price: $79.00

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.

In this webinar, you will learn how to complete a 510k Cover Letter and you will receive a 510k cover letter template.

Why you should register for the 510k Cover Letter Webinar?

A 510k Cover Letter needs to include the administrative information that is needed to properly identify you, your company, the 510k submission type, applicable regulations, product classification, the review panel, the device product code, and any previous submissions related to this 510k submission. The 510k Cover Letter also includes an eCopy statement (no longer required for a 510k due to FDA eSTAR template). There are also specific questions that the reviewer needs to answer about your product in order to identify specific specialists that may need to be involved, such as:

• Is the device provided sterile?
• Does the device contain a drug?
• Does the device use software?
• Does the submission include clinical information?
• Is the device implanted?

In addition to the 510k Cover Letter, there is also a submission cover sheet that must be prepared (i.e., FDA Form 3514). The submission cover sheet includes details that are used to create a database entry for you, your company, and your product submission. The submission cover sheet is also used for pre-submission requests, De Novo applications, and other types of device submissions. During this presentation, I will review each section of FDA Form 3514 and explain when each section applies and how to complete it. If you are looking for updated FDA Forms we have an article on this topic.

Does the Webinar Still Matter for the FDA eSTAR?

The FDA eSTAR incorporates all of the elements of FDA Form 3514, and you no longer have to fill in that form. However, the instructions for Form 3514 may be helpful. The 510k course we updated for the eSTAR shows how to fill in each section from beginning to end. The eSTAR has a section near the beginning where you need to attach a cover letter. The cover letter template we use in this webinar has only changed with regard to the eCopy statement.

What’s Included in the 510k Cover Letter Webinar?

• a recording of the webinar you can replay anytime
• my updated 510k Cover Letter Template
• a copy of FDA Form 3514
• a template I created for a supplement to FDA Form 3514
• the native slide deck for this webinar

This presentation has 22 slides and is 20 minutes long. It is recorded, but please email me questions at rob@fdaestar.com.

510k Cover Letter Webinar ($29)

510k Cover Letter Webinar

In this 20 minute webinar you will learn how to prepare a 510k Cover Letter and complete FDA Form 3514–including identification of recognized standards. You will also receive copies of the templates for both documents--updated for 2020.

Price: $29.00

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 sterilization validation webinar teaches you how to complete the FDA eSTAR section on sterility and how to avoid common mistakes.

Sterilization Validation Webinar – $79

When you develop a new medical device, one of the decisions you make is to select a method of sterilization. Most companies select a method based on what method competitor products are using. However, the method your competitors use should not impact the sterilization method you choose.

There is one method that is less expensive to validate than any other. There are also technical reasons for selecting one method instead of another. Finally, there are clear customer preferences for sterilization methods–depending upon who is using your device and in what environment

On October 10, 2024, we are updating our sterilization validation webinar to focus on three key factors:

1. What is required in the FDA eSTAR?
2. How do you select a sterilization method?
3. When should you avoid certain methods?

Sterilization Validation Webinar

This sterilization validation webinar teaches you how to complete the FDA eSTAR section on sterility and how to avoid common mistakes. This webinar also reviews the FDA guidance for sterilization validation.

Price: $79.00

When is the sterilization validation webinar scheduled?

This webinar will be live on Thursday, October 10, 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 sterilization validation webinar

The sterilization validation section of the submission is not just a paragraph referencing the recognized standards that were applied. Sterilization validation must be completed in accordance with the most recent standard regardless of which market you are seeking regulatory approval in. For FDA submissions, you are not required to submit your complete test reports for sterilization validation, but you must provide a thorough summary, or the FDA reviewer will request complete reports. This webinar will show you how to write that summary.

This sterilization validation webinar will also review the strengths and weaknesses of different sterilization methods. This will include both the category A sterilization methods (e.g., steam, gamma, and EO) and the category B sterilization methods. The selection of a sterilization method impacts your short-term verification and validation testing costs, but it also impacts how long validation will take and your long-term sterilization costs. Ethylene oxide used to be the most common sterilization method, but stricter environmental regulations are requiring that the medical device industry find innovative sterilization methods. We will discuss those newer methods during this webinar.

What you will receive for $79

• an invitation to participate in the live webinar (if you purchase before October 10, 2024)
• a recording of the webinar you can replay anytime
• the native slide deck for the sterilization validation webinar
• a copy of the FDA guidance for sterilization validation

The presentation will consist of 28 slides and will be ~50 minutes long. All content deliveries will be sent via AWeber emails to confirmed subscribers.

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  the  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.

In this 510k labeling and UDI requirements webinar, you will learn how to prepare an FDA eSTAR labeling section for medical devices.

Why you should register for the 510k Labeling Webinar

The 510k labeling and UDI requirements for 510k submissions have changed recently. Regulators have a long list of requirements that must be included for medical device submissions, and the current approach is risk-based.

What you will receive in the 510k Labeling Webinar

• a recording of the webinar you can replay anytime
• the native slide deck for this webinar

The presentation has 25 slides and is 43 minutes in duration. All content deliveries will be sent by email to confirmed subscribers.

510k Labeling Webinar ($49)

UDI-Labeling Requirements Webinar

In this webinar we will review the requirements for Section 13 of 510k submissions, and explain the process for creating labeling using a risk-based approach. In addition, we will address the UDI bar codes requirements for draft labeling submitted to the FDA.

Price: $49.00

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.

In this device description webinar series, you will learn how to write a device description for 510k submissions and CE Marking technical files.

Why you should register for the Device Description Webinar

The device description is not just a paragraph explaining what your device is. The device description comprises Section 11 of a 510(k) submission or the first section of a CE Marking Technical File. In the new FDA eSTAR templates, there is also a requirement for a detailed device description. Regulators have a long list of requirements that must be included for a 510(k) submission or a technical file. The wording of this section must include all the requirements or your regulatory submission will be placed on hold.

What you will receive for $29

• a recording of the four webinars you can replay anytime
• the device description template I use
• the native slide decks for the webinar

There will be 28 slides during the presentation. The presentation is 42 minutes in duration. All deliveries of content will be sent via AWeber emails to confirmed subscribers.

When is the Device Description Webinar?

The device description webinar was updated multiple times as submission requirements have changed:

• October 14, 2016
• March 10, 2022
• April 8, 2022
• November 17, 2022

All four recordings are available when you purchase this webinar.

Device Description Webinar ($29)

Device Description Webinar

In this webinar we will explain why the various details in the device description template are required and how to complete each section. The webinar will be 50-60 minutes in length. You will receive access to the live recording, the native slide deck and a blank template for device descriptions intended for 510k submissions and CE Marking technical files.

Price: $29.00

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 Google+, LinkedIn, or Twitter.