Surviving an MDSAP Inspection: A Guide for Devicemakers

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Surviving an MDSAP Inspection
A Guide for Devicemakers

Currently, Australia, Brazil, Canada, Japan and the United States are participating in the MDSAP program. If you pass one MDSAP inspection you’ll be ready to pursue marketing authorization in five separate countries.

But, if you’re going through MDSAP for the first time your experience will be very different from regulatory inspections you’ve gone through in the past.

  • You’ll know exactly when and how often to expect an audit
  • You’ll know exactly how long the audit will be
  • You’ll know exactly what questions the auditor will ask

The prescriptive nature of the MDSAP model makes it relatively easy to prepare for an audit — if you know what to expect. Surviving an MDSAP Inspection provides all the information you’ll need to understand the MDSAP model.  You’ll learn:

  • The standard schedule for and duration of audits
  • Specific areas auditors will examine and questions they will ask
  • Different types of audits involved, such as initial certification, surveillance, desk and site audits
  • How to create a checklist to make sure all your bases are covered
  • The MDSAP grading system and how nonconformance issues can be escalated — and consequences of getting a bad grade

The management report also includes a copy of the MDSAP Companion document — the official guide — auditors will follow.

Order your copy of Surviving an MDSAP Inspection: A Guide for Devicemakers and know what to expect from an MDSAP audit and how to prepare for it.

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Table of Contents

  • Introduction
  • What to Expect from an MDSAP Audit
  • Preparing for an MDSAP Audit
  • Lessons Learned from MDSAP Audits
  • And More …

View the entire TOC

Who Will Benefit

  • Quality management leadership
  • Operations managers
  • Regulatory compliance officers

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