In this 510k project management webinar you will learn lessons from the mistakes of others. Great lessons are usually learned the hard way–by making mistakes. However, sometimes you can investigate the mistakes of others and avoid these painful mistakes. You can also learn by analyzing trends in the FDA database for 510k issuance. This webinar covers the following valuable lessons:
- check recognized standards again,
- converting special to a traditional,
- abbreviated 510k timelines,
- requesting a 510k statement early,
- inadequate classification search,
- using too many planning tools,
- firmware is software too,
- believing vendor promises,
- failure to review test reports,
- last minute edits to eCopy, and
- RTA response letters.
This webinar was recorded live on Friday, August 12. Anyone purchasing this webinar will receive a recording of the webinar and a copy of the native slide deck for $129. The presentation slide deck includes 27 slides during the presentation. The presentation is slightly longer than an hour–including the Q&A session.
Please submit questions to me by email at firstname.lastname@example.org regarding the 510k Hardware and Software Documentation Webinar.
510k Project Management Lessons Learned Webinar available for $129.
In this 510k project management webinar you will learn lessons from the mistakes of others. This live webinar will be 50-60 minutes in length. You will receive access to the live recording and the native slide deck.
- 510k Hardware and Software Documentation Webinar – $129
- De Novo Application – $129
- How to Combine a 510k Submission with CE Marking and Reduce Your Workload by 35% – $129
- FDA Pre-Sub Meetings – $129
- 510k Submissions: Predicate Device Selection – $129
- 510k Submissions: Substantial Equivalence – $129
- 510k Submission Section 4: Indications for Use – $129
- 510k Project Management Webinar – $129
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years 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 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. 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 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.