GXP

The MDSAP Audit Experience

The Medical Device Single Audit Program (MDSAP) is a new medical device auditing plan with potential for several advantages.  This discussion addresses an actual MDSAP audit experience and demonstrates how the organization dealt with its complexities.  The MDSAP program is described including country involvements.  Audit personnel and experiences are discussed.  Example documents are described.  An example hourly schedule is presented.  The observation rating system is described and example audit finding are presented.  Differences compared to and FDA audit are considered.  The MDSAP is the biggest change in medical device regulations since the introduction of the European MDD in the 1990’s.  Time will tell whether MDSAP will ultimately lead to a better quality in design, manufacturing, and regulatory control.

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