MassMEDIC News


		April 2005

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MassMEDIC's March 1 seminar on regulatory and safety standards featured presentations by (from left): Jeff St. Onge, Chief Engineer, QuadTech, Inc.; Frank O'Brien, President, O'Brien Compliance Management; Harvey Rudolph, Ph.D., General Manager, Medical Devices Unit, Underwriters Laboratories, Inc; Dave Osborn, Regulatory Affairs, Philips Medical Systems; and Robert Brown, Vice President, Technical Operations, QuadTech, Inc.

MassMEDIC launched a busy spring calendar on March 9 with a seminar on “Medical Device Regulatory and Safety Standards – An Update.”

Representatives from independent testing firms QuadTech, Inc. and Underwriters Laboratories reviewed current and forthcoming standards in risk management, product safety and quality assurance. Presenters also provided attendees with best-in-class examples of automating safety testing, implementing device standards and managing compliance from Philips Medical Systems and O’Brien Compliance Management. Please click here to view the presentations from this seminar.

On March 10, the Canadian Consulate General hosted a symposium for MassMEDIC members on “Partnering with Canadian Medtech Companies.” The session featured presentations of the innovative medical technologies being developed by 12 Canadian companies, including NIR Diagnostics and Orthopedic Alignment and Imaging Systems. Dr. Ian Smith, Director General of the Institute for Biodiagnostics (NRC) in Winnipeg provided the keynote address with a briefing on his research center’s activities and mission. To help advance US-Canadian medtech industry collaboration, a number of symposium participants held one-on-one meetings with the presenting companies to discuss development and distribution partnerships.

At MassMEDIC’s March 24 seminar, “Design for Six Sigma – Designing Quality into Medical Devices”, Kevin Otto, Lead Consultant at Product Genesis and a Master Black Belt in Six Sigma, opened the session with an overview of Design for Six Sigma (DFSS) principles, including an analysis of the quality improvements and cost-savings achieved by companies that have adopted DFSS. Dan Dillon, a consultant with Medical Device Consultants, Inc. discussed how companies should integrate DFSS guidelines with the FDA’s requirements for design controls.

The session also featured more than an hour of audience Q&A with representatives from Boston Scientific, DePuy Spine, Philips Medical Systems and Tyco Healthcare who provided valuable insight into their companies’ implementation of DFSS and the critical “lessons learned” that resulted. Please click here to view the presentations from this seminar.