AAMI, FDA Host Conference on Medical Device Standards and Regulation


Sponsored jointly by AAMI and the FDA, the 21st Annual International Conference on Medical Device Standards and Regulation will provide up-to-date, detailed information about some of the latest standards and regulatory initiatives that affect manufacturers of medical devicesboth in the U.S. and overseas. Participants will hear from representatives of the FDA and members of international standards committeesand learn what they need to do to comply with recent changes to industry standards.

Sessions include:

Wednesday, March 23

- Panel Discussion on the Importance of Device Standards Using a "System of Systems" Approach

- A Case Study on Assurance Use Cases

- Assessing the Impact of the New 510(k) on Standards

- A Discussion on the European Standards Program: Post-Market Surveillance, the Impact of Medical Devices Directive Changes and Recent Changes to the Infrastructure

- The Potential Impact of Home Healthcare on the Standards and Regulatory Environment

Thursday, March 24

- Evaluating the Impact of the Medical Device Data System (MDDS) Rule

- A Review of the FDA's Unique Device Identification (UDI) Rule

- Dealing with Conformity Assessment to IEC 60601-1 3rd Edition and a Review of Amendment 1

- A Discussion on Emerging Markets (India and China)

- Data Security and Privacy Concerns for Medical Device Manufacturers

- Briefing on Current Standards Activities

To register, visit: http://www.aami.org/isc/

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