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 Inspectionprovides 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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