Regulations

Eurofins Medical Device Consulting utilizes global expertise to support marketing authorization and commercialization. Our supported geographies include:

• United States: U.S. Food & Drug Administration - 21 C.F.R. Part 800 – 898
• European Union: Medical Device Regulation (EU MDR)
• European countries that are not part of the EU
• LATAM (Latin America), APAC (Asia Pacific), Australia, Japan and more…