Learn how you can organize the content of 9 sections of your 510k submission so that you can easily re-purpose the content for a Technical File or Design Dossier for a CE Marking Submission.
There are 20 sections required by the FDA for a Traditional 510k submission, but often some of the sections are boilerplating, while other sections are not applicable to the device being submitted at all. In this webinar, you will learn which of the 20 510k sections can be reused for your Technical File and Design Dossier. You will also learn which sections of your CE Marking submission must be added to your combined regulatory plan in order to prepare both submissions in parallel for a shorter time to market.
This webinar includes the following:
- Project management tools and templates
- Comparison of 510k and Technical File / Design Dossier requirements
- References to US & European guidance documents
- Suggested timing for the overall combined regulatory plan
510(k) Medical Device Academy Training Overview
- When: Wednesday, June 17, 2015
- Time: 9:00 AM Eastern Time
Who should watch?
- Regulatory Affairs
- Product Development / R&D
You will be able to ask questions during this live webinar session. You will also receive a link for downloading the recording of the webinar.
If you can’t make the live session, register anyway and submit your questions to me by email. You will still receive a recording of the webinar and a copy of the native slide deck.
Please Note: Purchase of the webinar includes the native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.
Webinar slide deck and recording will be delivered by email.
About Your Instructor
Robert Packard is a regulatory consultant with 20 years 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. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’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. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.