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Regulatory Affairs, Medical Devices

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


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

  • An opportunity for quality

  • Software solutions to streamline audit tasks

  • ResMed - a successful case study

  • The growing membership and benefits

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