Join us in Spring 2022 for our online medical device submissions workshops, including: 510(k)/De Novo Submissions, IDE Submissions and PMA Submissions. This is the ideal introductory program for professionals who are new to regulatory affairs and want an incredible opportunity to learn more about regulatory requirements for bringing products to market. More details will be announced in the coming weeks. Click here to sign up to receive updates.
Who should attend?
Who should attend?
- Medical device professionals new to the FDA regulatory submission process
- Regulatory Affairs Professionals
- Regulatory Compliance Professionals
- Quality Assurance Professionals
- Regulatory Affairs Rotational Associates
“The AdvaMed Submissions Workshops were very informative and helpful. In particular, hearing from experts in the regulatory field and representatives from the FDA was a great plus. It is one thing to just read the regulations, but it is extremely beneficial to have first-hand guidance from the experts.”
– Regulatory Affairs Manager, Terumo Aortic
Attendee learning objectives
- Guidance for 510(k), De Novo, IDE and PMA submissions
- Considerations for determining a product’s regulatory route to market
- Tips on making the best use of pre-submission meetings
- What to expect during a submission review
- Preparation needed for an advisory panel meeting
- How to deal with unexpected clinical outcomes, animal test results and adverse panel recommendations
- The ins and outs of BIMO inspections
- Overview and strategy for De Novo
“It was incredibly beneficial as a recent graduate to have had the opportunity to sit down with highly experienced professionals in the medical device field and focus on the topic of 510(k) submissions. I’m now able to come back to my company with significant knowledge I didn’t have before and get a jump start in applying it.”
– Rotational Associate, Regulatory Affairs, Integra LifeSciences