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Events, Professional Development

Product Registration and Quality Management System Requirements for Medical Devices!

Posted: October 7, 2016 at 12:30 pm   /   by   /   comments (0)

Professional Development Event
Professional Development Events are Open to all Public. No membership required.

Topic:
Product Registration and Quality Management System Requirements for Medical Devices!
Wednesday (5:30 PM – 9:00 PM)
October 19, 2016


Presenter:
Rob Matheson
Director Regulatory Affairs at CV Diagnostix
Ottawa, Canada
Event Location:  View Map
Centurion Conference & Event Center,170 Colonnade Rd, Ottawa, ON K2E 7J5.
Program Details:
Networking: 5:30 p.m. To 6:00 p.m.
Buffet Style Dinner: 6:00 p.m. To 7:00 p.m.
(Please bring $20.00 cash for the buffet)
Presentation: 7:00 p.m. To 9:00 p.m.
Students who do not wish to take part in the dinner and networking may arrive at 6:45 p.m. for the 7:00 p.m. presentation — $5.00 at the door.
Synopsis:
Medical devices are highly regulated in all phases of the product lifecycle. The current compliance environment is evolving quickly as standards and regulations try to keep pace with technological developments and as emerging and established regulatory schemes attempt to make devices safer and more effective. This presentation will introduce the product registration and quality management system requirements currently in place for medical devices in the USA, Canada and elsewhere. The presentation will also highlight some significant challenges that industry compliance professionals will be facing within the next few years.

Rob Matheson is a medical device compliance professional with over 16 years of experience managing regulatory affairs and quality management systems. He has worked on a number of products including clinical chemistry tests, point of care devices, sleep and neurodiagnostic systems, genetic sampling and specimen storage devices, electronic health records and most recently, cardio acoustic diagnostic systems. Worked for large and small organizations (global giants like Abbott and Covidien/Tyco, innovative newcomers like DNA Genotek and CV Diagnostics). He holds the ASQ CMQ/OE certification and is a BSI 13485:2003 certified auditor.

Register to enjoy this wonderful presentation and this unique opportunity to exchange experiences and share ideas.
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