Author: Suzanne Broussard
Risk Assessment is the Cornerstone of the MDSAP
When preparing for the MDSAP audit, it is important to understand that the audit focuses heavily on risk-based processes, outsourced processes, and validation activities. MDSAP is based on the international quality systems standard ISO 13485:2016, which requires organizations to consider risk from device conception through its lifetime of use. This Risk Management includes the device manufacturer and the supply chain.
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There are seven “Processes” in the MDSAP audit. FDA’s vision of how all these processes link together is depicted in Figure 2.
The first four “Primary” processes, depicted in
the dark blue boxes, and the “Supporting” Purchasing process were all built on
a foundation of Risk Management. The other two Supporting processes (note that Device
Marketing Authorization and Facility Registration links to two processes),
depicted in the light blue boxes, fulfill the requirements of the participating
regulatory authorities. There are 90 total tasks.