This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Regulatory Affairs, Medical Devices
search

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

ArticleImage

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


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.

Log in or Create an Informa Connect Account to Access this content

Creating an account also means you'll get special access to article updates and exclusive industry content.