Canadian Medical Device Regulations (CMDR)
Schedule:
- 7 Oct 2008, 1:00 pm Eastern
Duration: 2 hours with questions and answers
Synopsis: Canada is the US’s English speaking neighbor and their medical device regulatory requirements are modeled after the European CE Mark process, but that is where the similarities end! Canada is a unique jurisdiction that aggressively enforces its own regulations. This webinar outlines the smooth integration of Canadian regulatory requirements into your manufacturing and quality management systems processes and reviews the Canadian regulatory structure including registering your site and obtaining medical device licenses and will include insight you can use on:
- CAN/CSA ISO 13485 quality management systems
- Product safety and effectiveness
- Identifying and using recognized Standards
- Selecting the correct CMDCAS Registrar
- Unique Canadian regulatory requirements such as supplier/subcontractor approval, post market surveillance
- Medical device license application and establishment registration
- Instructions for Use and product labeling, and
- Distributor's responsibilities
Description: This webinar outlines Canada’s unique requirements and demonstrates several ways that, with a little planning, a manufacturer can fully integrate those requirements into their existing regulatory and quality processes.
Who should attend: This webinar is ideal for regulatory compliance and quality management staff and those individuals who have to manage processes, conduct research and development, organize product testing or prepare regulatory applications as well as those who must interact with auditors and inspectors.
Presenter: Tim Duggins, Horizon Phoenix’s Senior Partner has more than 25 years experience in medical device quality systems and product testing. Tim is a skilled and fully accredited consultant and auditor with extensive experience implementing fully compliant regulatory and quality systems using EN/ISO 13485, USFDA QSR, Health Canada CMDR and/or all medical European Directives for more than 100 clients. An avidly sought after expert, he served as a consultant to such diverse organizations as federal governments, international non-governmental organizations, and industry from multi-national manufacturers to a three-person niche-market company. Tim has participated on numerous national and international committees writing product testing standards and helping create government regulatory processes; his product experience spans the entire medical device spectrum from high volume injection molded disposable products, digital radiography systems, in vitro diagnostic test kits to implantable cardiovascular devices.
Expert contributor: TBA
Expert contributor: TBA 11 Mar 2008
Registration:
$295
Registration for Oct 7th will
be set up at a later date...
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