World MedTech Regulatory Update

When: « Back to Calendar June 8, 2017 @ 8:00 am - 3:00 pm
Where: Massachusetts Medical Society
860 Winter St
Waltham,MA 02451
Cost: $ 175
Contact: MassMEDIC
Categories: MassMEDIC Events

The same organizations that bring you the Annual FDA Update program each December – ASQ Biomedical Division/New England Discussion GroupMassMEDIC and RAPS – present World MedTech Regulatory Update. Join your medical device colleagues for a day of briefings on breaking regulatory news from the EU, South America and Asia. This day-long session will feature presentations on the European Union’s Medical Device Regulations; implementation of EN 13485; the IVD Regulations; MEDDEV 2.7.1 Rev 4, Clinical Evaluation; the MDSAP Audit Process, along with updates on device regulations in China, South America and India.



7:30 a.m.

Registration / Continental Breakfast / Networking


8:00 a.m.

Welcoming Remarks

EU – Current Status of Medical Device Regulations
Agnieszka Jarmula, Esq., Senior Advisor, Food Safety, Health and Consumer Affairs, Delegation of the European Union to the United States


8:30 a.m.

Implementation of EN 13485 – Strategies for Success
Mark Swanson, Director of Operations for Upper Great Lakes Region, Regulatory and Quality Solutions


10:30 a.m.

Networking Break 


11:00 a.m.

IVDR Update – Get Ready for the Ride
Carol Ryerson, Senior Principal Advisor, RCRI


11:30 a.m.

MEDDEV 2.7.1 Rev 4, Clinical Evaluation
Alan Eller, Vascular Product Expert, BSI


12:00 p.m.



1:00 p.m.

The MDSAP Audit Process: Everything you always wanted to know about MDSAP but were afraid to ask!
Connie Hoy, EVP Regulatory Affairs and Clinical Development, Cynosure, Inc.


2:00 p.m.

Asian Update
An overview of key regulatory changes and requirements in Japan, China, and India
Ames Gross, Pacific Bridge Medical


3:00 p.m.

Conference Adjourns