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QM Requirements for Medical Devices in the USA
The U.S.-EU Mutual Recognition Agreement (MRA) and the U.S. Medical Device User Fee and Modernization Act now permit inspection by third parties and accredited persons (APs). Only the FDA was previously authorized to undertake these inspections.
Manufacturers of Class II and Class III products can use AP/MRA programs. We are an accredited third party for both programs.
Your Benefits as a Manufacturer
We offer you the opportunity to carry out FDA inspections in combination with audits based on other regulatory requirements such as those of the EU (MDD, AIMD, IVDD) and Japan (PAL) which can save your time, resources and money.
The AP/MRA programs also enable you to exert more influence on inspections. Not all companies registered with the FDA are inspected regularly by the FDA. However, statistics show that there is a greater degree of compliance with U.S. statutory requirements if companies are inspected regularly.