The regulatory climate for medical devices is constantly evolving as technologies improve and market (post-production) experience expands. The international standards for Medical Device Quality Systems, Risk Management, Basic Safety, Essential Performance, and EMC are changing as well. Learn up-to-date, detailed information about how these changes redefine the benchmark for acceptable product life cycle processes and risk and their impact on many functional groups within a medical device company.

Speakers include: a representative from a European Notified Body; IEC 60601, SC62A committee members; a manufacturing engineer familiar with automation production safety testing; and a regulatory affairs manager responsible for implementing these new standards.

MEETING AGENDA


7:30 a.m. Registration/Continental Breakfast/Networking

8:00 a.m. Welcome & Introduction

Program Moderator: Robert Brown,
V.P. Technical Operations – QuadTech, Inc.

Medical Device Quality Systems and Risk Management

Steve McRoberts, UL International, Lead Auditor

Medical Device Basic Safety, Essential Performance, EMC

Frank O’Brien, O’Brien Compliance Management
Secretary, SC62A/WG17

Automating Production Safety Testing – A Case Study

Jeff St. Onge, Chief Engineer – QuadTech, Inc.

Implementing New Medical Device Standards – An Industry
Perspective

Dave Osborn, Regulatory Affairs, Philips Medical Systems
Convener, SC62A/WG5

10:30 a.m. Program Adjourns


MassMEDIC gratefully acknowledges
QuadTech, Inc. and Underwriters Laboratories, Inc.
sponsors of this program.

Register on-line

715 Albany Street, TW1   Boston, MA 02118   tel: 617 414 1340   fax: 617 414 1344   info@massmedic.com