FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS

When: « Back to Calendar December 8, 2016 @ 8:30 am - 3:00 pm
Where: Massachusetts Medical Society
860 Winter St
Waltham,MA 02451
Cost: $ 175
Contact: MassMEDIC
Categories: MassMEDIC Events



This Program is sold out. Unfortunatley we can not accomidate walk ins.

Collaboratively hosted by the ASQ Biomedical Division/New England Discussion GroupMassMEDIC and RAPS, this daylong program is designed to give RA, QA and C-level executives a one-day crash course on the pending regulatory issues facing the industry. The agenda will include comprehensive presentations by FDA officials, industry representatives and regulatory experts.



7:30 a.m.

Registration / Continental Breakfast / Networking

8:30 a.m.

MassMEDIC – Tom Sommer, President

Election 2016 – Impact on the MedTech Industry
Gregory Levine, Partner, Ropes & Gray

FDA EFS-IDE Program: Experiences and Lessons Learned
Marybeth Gambler, Principal and Mack Rubley, Vice President, Boston Biomedical Associates 

The Office of Device Evaluation: Strategic Initiatives; Quality Systems; and MDUFMA IV
John Sheets, Ph.D, Director, Office of Device Evaluation, CDRH/FDA

10:00 a.m.

Networking Break 

10:30 a.m.

RAPS – Sue Hamann, Chapter Chair, RAPS Boston Chapter

FDA District Office Update
Joseph Matrisciano, Jr. , Director, New England District Office, FDA

Changes in the RA/QA Environment that Every Device Manufacturer Needs to Know
Paul Brooks, Executive Director, RAPS


12:00 p.m.


1:00 p.m.

ASQ Biomedical New England Biomedical Discussion Group –
David Leo, President, Biomedical Resource Consultants, Inc.; Past Chair ASQ Biomedical / Co-Founder NEDG

MDSAP – An FDA Perspective
Captain Kimberly Lewandowski-Walker, National Expert, Medical Devices:
FDA, ORA, Office of Medical Products and Tobacco Operations

MDSAP – A Notified Body’s Perspective
Tamas Borsai, Division Manager, Customer Service & Quality, TUV SŰD America

Joint Q&A
Moderator: Paul Brooks, Executive Director, RAPS


3:00 p.m.

Conference Adjourns