Date: Wednesday, April 22, 2015
Venue: Alt Hotel
Address: 6080 Airport Road, Mississauga, ON
Update on EU Regulatory Requirements for Medical Devices and Understanding CE Marking Technical Documentation/Clinical Evaluation Expectations
BSI is pleased to be supporting the medical device manufacturer regulatory affairs and quality assurance professionals by offering the opportunity to attend our second annual Mini-Roadshow program. Our exclusive half-day Roadshow program will provide the latest update on topical changes proposed on European medical device regulations, ISO 13485, MDSAP and Unannounced Visit experience.
Key technical sessions will also review current expectations and best practices for CE Marking clinical data evaluation and common problems with technical documentation supporting compliance with EU medical devices directives.
Also showcased during the morning will be an innovative new solution for managing and maintaining awareness of the latest draft/published standards to support medical device compliance and an effective tool for managing QMS actions. We invite you join the BSI experts to discuss critical topics and receive valuable timely insights from the perspective of the leading North American CE Marking medical device Notified Body, ISO 13485 registrar and the first national standards body.
8:00 – 8:30 a.m. Registration and Breakfast
8:30 a.m. – 12:30 p.m. Meeting (see event topics below)
12:30 – 1:30 p.m. Networking Lunch
BSI is the world’s first national standards body partnering with medical device manufacturers to provide impartial third-party standards based assurance, compliance, information solutions, and training. Backed by 80,000 client locations in over 100 countries, and more than 50 BSI offices, we are the trusted partner of Industry and Government professionals all over the world.
The Support of an Industry-Leading Medical Device Team
BSI is an approved “full scope” Notified Body, recognized by the European Commission for 17 directives and by the FDA, CMDCAS, JPAL, LG/ZLS, and TGA. Every day, we work with our customers to deliver on our global mission: To ensure patient safety while supporting timely access to medical device technology.