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Regulatory Affairs, Medical Devices

Notified Body designation and scope, the impact of Brexit and Competent Authority and Notified Body interpretation of the regulations. Make sure you are up to date!

Preparing your organisation for MDSAP: Australia, Canada, Japan, Brazil - WHITEPAPER

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Download the exclusive whitepaper

The International Medical Device Regulators Forum (IMDRF) established the Medical Device Single Audit Program (MDSAP) in order to develop a standard set of requirements for Certification Bodies to perform regulatory audits to the quality management systems of Medical Device manufacturers ruled by different authorities.

Following the pilot program with international members - Australia, Canada, Japan and Brazil - the FDA has agreed to continue to accept MDSAP audit reports as a substitute for routine Agency inspections. This whitepaper details how your organisation can prepare for MDSAP, including:

  • Major challenges

  • 一个机会佛r quality

  • Software solutions to streamline audit tasks

  • ResMed——一个成功的案例研究

  • The growing membership and benefits


To download simply log in or register for an Informa Connect account, which will give you access to all our exclusive premium content. Have any questions or interested in sponsoring future content? Email andrew.burrows@informa.com.

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