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QM Requirements for Medical Devices in the USA
The United States is one of the most important markets for medical devices. To achieve success there, European manufacturers must fulfill the requirements of the Food and Drug Administration (FDA).They include the requirements for a quality management system to monitor development, production and product distribution in the U.S. market.
Why AP/MRA programs
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) – and save time, resources and money.
The AP/MRA programs also enable you to exert more influence on the timing of inspections. Not all companies registered with the FDA are inspected regularly by the FDA, but statistics show that there is a greater degree of compliance with U.S. statutory require¬ments if companies are inspected regularly.
How do you go about it?
- Simply contact us and we will assess with you the possibility of taking part in one of the two programs.
- You apply to the FDA for an inspection to be carried out by the TÜV Rheinland Group.
- Once the FDA has given the go-ahead, we carry out the inspecttion at your company.
- We then draw up a report for the FDA.
- The FDA will conduct a final assessment based on the TÜV Rheinland Group’s report.