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Audio conference highlights

Despite the downturn in the global economy, Canada remains an important and growing market for medical device manufacturers. However, differences between Health Canada and FDA regulations and device classifications have resulted in some confusion over the best approach to take when entering the Canadian marketplace.

This presentation covers the basic steps you will need to take to obtain the appropriate licences for your company and/or medical device (e.g. Medical Device Licence or Medical Device Establishment Licence). The presentation includes a discussion about the Canadian Medical Device Regulations, the role of ISO 13485:2003 CMDCAS, and issues related to language translation.

This audio conference covers:

• Overview of Canadian Medical Device Regulations (CMDR)
• Medical Device Licensing - Class II, III & IV Medical Device Manufacturers
• Medical Device Establishment Licensing - Class I Medical Device Manufacturers
• Medical Device Establishment Licensing - Medical Device Manufacturers Distributor
• Private Label Medical Device Licence
• Role of ISO 13485:2003 CMDCAS

About the speaker:

Daryl Wisdahl is Managing Director of Wisdahl Consulting Group, a consulting firm focusing on regulatory, quality and clinical research issues for small medical device companies. Daryl has over 15 years of regulatory affairs, clinical research, quality assurance and marketing experience in the medical technology industry. He works directly with start-up companies, and has assembled Health Canada regulatory submissions for companies around the world. Prior to starting Wisdahl Consulting Group, Daryl held positions in his fields of expertise with a number of Canadian medical device companies. He holds a Regulatory Affairs Certification (RAC-US) from the Regulatory Affairs Professional Society (RAPS) and has a Bachelor of Business Administration from Simon Fraser University.

Who should attend?

• Regulatory affairs
• Quality assurance
• International sales
• Business development
• Marketing
• Legal counsel
• Senior management

This audio conference is rated General Interest.

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.

ForeignExchange Translations provides specialized French-Canadian translation services to medical device and pharmaceutical companies.