FDA ( Food and Drug Administration)
Required in the United States, the regulations used are CFR 21 Part 11 (CFR=Code of Federal Regulations), Electronic Records and Electronic Signatures, and 21 CFR Part 820 Quality System Regulations (QSR), outlines Current Good Manufacturing Practice CGMP regulations that govern the methods which must apply to the development of software that acts as a component of a medical device. Companies who comply with the PMA FDA regulations recieve the FDA Approval.
Companies who comply with the 510(k) clearance are 510(k) cleared, but not FDA Approved.
MDD – European Medical Device Directive 93/42/EEC
European standard for risk protection associated with the design, manufacturing and packaging of medical devices. Compliance with the requirements of the MDD is declared by placing the CE marking on the product, which supply the device with a comfofmity decleration[/vc_column_text][/vc_column][/vc_row]