MDSAP
MDSAP Mock Preparation
The Medical Device Single Audit Program (MDSAP) is a cooperative program between the US FDA, Canada, Brazil, Japan, and Australia. The goal is to lessen the repetitive audit burden placed upon medical device companies by using a single audit to demonstrate compliance in all five countries. Health Canada is leading the way and will require MDSAP certification in January 2019.
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An MDSAP audit differs from a typical FDA inspection or Notified Body audit. The scope of the audit often extends well beyond your quality management system procedures, deep into regulatory compliance. It is not unusual for an MDSAP audit to be conducted by two auditors plus observers from the FDA, Health Canada.
MDSAP
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