Why Do You Need to Attend this Virtual Conference

Keynote Speaker: Melissa Torres, Associate Director for International Affairs, CDRH, FDA

Massive changes are afoot in global regulatory and quality requirements for the medical device industry, including the European medical device and in vitro diagnostics regulations, new clinical evidence requirements, updated standards, and mandatory participation in the MDSAP program for those wishing to distribute products in certain markets.

The new European device and diagnostics regulations will dramatically affect both new and legacy products.

Manufacturers need not only to change current procedures but to evaluate and remediate legacy products that will remain on the market. There are phase-in periods for the new requirements, but they are never as long as one might like, and there are always unanticipated complications and delays.

The time for reassessment of product portfolios and strategic planning for procedural changes is now!

Strategic planning, assessment of products and procedures, and the design and implementation of new SOPs are complex, costly, time-consuming activities. And there will be fewer and more overworked notified bodies to assist companies in the future.

In this highly interactive Virtual Conference, FDA, the two largest and most experienced notified bodies, together with experts from companies well advanced in planning for the upcoming changes, present the issues and requirements, experience, and best practices for efficient compliance and remediation.

CEU Information

Attendees can earn CEUs. 1 hour of the conference = .1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.


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