Master 510(k), IDE, and PMA Submissions at AdvaMed's Workshops

Within driving distance to D.C.? There's still time to enjoy a few days there next week and simultaneously hone your submissions skills. The FDA, R&Q, and other talented industry experts courtesy of AdvaMed are offering three workshops dedicated to teaching you the guidelines for successful 510(k), IDE, and PMA submissions. Engage in interactive workshops and hear from industry professionals - such as R&Q's Director of Regulatory of Affairs Nancy Morrison and Senior Principal Advisor Marilyn Waxberg. The AdvaMed events are some of the best in the business, and R&Q is proud to be included as part of the faculty. Read on for details! 

510(K) Submissions Strategy Workshop: Oct. 31-Nov. 1

FDA and industry experts are coming together to teach you the basics of 510(k) submissions.

Agenda topics include:

• FDA’s updates to the 510(k) process
• Different types of 510(k)s
• Considerations for determining a product's regulatory route to market
• Factors to consider when planning and assembling a 510(k) submission
• Tips and hints on interacting with FDA during the 510(k) review process
• Deciding when to submit a new 510(k) for a device modification
• And more

Get the full agenda. 

Investigational Device Exemption (IDE) Submissions Workshop: Nov. 2

During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required.

Agenda topics include

• The purpose of an IDE
• Tips on making the best use of pre-submission meetings
• Components of a successful IDE submission
• Common errors and deficiencies in an IDE application
• The ins and outs of BIMO inspections
• Details about the regulatory requirements needed during trial conduct
• And more

Get the full agenda. 

Premarket Approval (PMA) Submissions Workshop: Nov. 3-4

Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a Premarket Approval.

Agenda topics include:

• Steps to develop a PMA submission strategy
• Best practices of quality system information for PMA applications
• What to expect during a submission review
• Preparation needed for an advisory panel meeting
• Tips to prepare for an inspection
• Ins and outs of BIMO inspections
• How to deal with unexpected clinical outcomes, animal test results, and adverse panel recommendations
• Needed supplemental submissions for approved PMAs
• Real world case studies
• And more

Get the full agenda.

As always, see these and more opportunities to improve your medical device business on our Events page.