The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Medical Device Regulatory Audit Reports



Document Type:
The scope of this guidance document is limited to the information that participating MDSAP Regulatory Authorities require in medical device regulatory audit reports, the format of reports and the information necessary for participating MDSAP Regulatory Authorities to effectively use the audit reports in accordance with their legislation.

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