MDSAP Insights

What is MDSAP?

MDSAP stands for the Medical Device Single Audit Program. It's a program that allows medical device manufacturers to be audited once for compliance with the regulatory requirements of multiple countries. A single MDSAP audit can satisfy the requirements of regulatory authorities in participating countries, reducing the burden on manufacturers and streamlining the regulatory process.

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What other technologies are related to MDSAP?

MDSAP Complementary Technologies

ISO 13485

ISO 13485 is a quality management system standard that is the foundation for MDSAP audits. MDSAP audits often leverage ISO 13485 as the base standard.

mentioned alongside MDSAP in 7% (868) of relevant job posts

EU MDR

The EU MDR is a regulatory framework for medical devices in Europe. MDSAP can be used to demonstrate compliance in some aspects of the EU MDR.

mentioned alongside MDSAP in 20% (180) of relevant job posts

MDD 93/42/EEC

The MDD 93/42/EEC is a regulatory framework for medical devices in Europe which the EU MDR replaced. MDSAP can be used to demonstrate compliance in some aspects of the replaced directive.

mentioned alongside MDSAP in 42% (58) of relevant job posts