Using the MDSAP Model to Win International Device Approval

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Using the MDSAP Model to Win
International Device Approval

Do you want to be one step closer to getting your product on the international market?

Consider implementing the Medical Device Single Audit Program — MDSAP.

It's a single audit of your quality management system and satisfies the medical device regulatory authorities. Currently, Australia, Brazil, Canada, Japan and the United States are participating in the program. If you pass one MDSAP inspection then you will be ready to pursue marketing authorization in five separate countries.

The Using the MDSAP Model to Win International Device Approval management report explains what MDSAP auditors will focus on and teaches you how to build an internal audit program that will get your quality system in state-of-the-art shape for international inspections.

You will learn:

  • How to conduct an audit covering the standards and regulations addressed under the MDSAP model
  • How to identify and understand the requirements as interpreted by the various regulatory authorities
  • How to determine gaps in your current documentation
  • How to "score" your current quality system
  • How to improve the predictability of an audit outcome
  • How to report the audit findings using a standard report template
  • Learning the benefits of enrolling in the MDSAP

Order Using the MDSAP Model to Win International Device Approval and get ahead of the game by learning how to handle this new inspection model.

 

PDF Edition

 

Available Format

PDF Edition — $397

Who Will Benefit

  • Auditing and compliance officers
  • QA/QC managers and directors
  • Regulatory/compliance staff
  • International development department

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