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  • Global Medical Device Laws and Regulations: US, EU, and

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Jun 18, 2013 10:00 AM
  • End Time:
  • Tuesday - Jun 18, 2013 11:30 AM
  • Location:
  • Online
  • This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.

    Why Should You Attend:

    Global regulations of medical devices are rapidly evolving, integrating the regulatory systems of the advanced medical device regulations. To be able to achieve sustainability and to remain sustainable and competitive in global medical device markets, it is necessary to streamline the regulatory process. To do so, we should understand differences in regulatory frameworks (regulatory requirements and compliance) in a sustainable and effective way.

    This 90-minute training will discuss medical device laws and regulations in the USA, EU and Canada. It is intended to guide you through to understand and accurately interpret applicable laws and regulations governing medical devices in the above global countries. The presenter will guide participants from the medical device industry to streamline their business planning and regulatory strategy in these global markets.

    Areas Covered in the Webinar:

    - Medical device laws and regulations in the US, EU and Canada.
    - Definitions
    - Regulatory framework for medical devices in the US, EU, and Canada
    - Device classification
    - Regulatory requirements for medical devices including in vitro diagnostic devices in the US, EU and Canada.
    - Contents of a 510(k) and PMA in US
    - Contents of a technical file and design dossier in EU
    - Content of a medical device license application in Canada
    - How to identify and meet the regulatory requirements.
    - How to establish and maintain systematic methods to meet the regulatory requirements.
    - How to streamline the regulatory process
    - Instructor’s unique regulatory guide.
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