regulation

Regulatory processes for medical devices:

For the production and marketing of medical devices, the human factor requires strict regulatory requirements. There are standards and standards such as QS of the American FDA (21 CFR Part 820), and the international ISO 13485, also considering the lifetime of the device which covers the development, packaging, production, use and even its disposal due to its being disposable.


As part of our expertise in the standard requirements for medical devices, Paramedical assists in clinical and pre-clinical trial processes, examines biocompatibility, sterilization capacity, safety and risk management, as well as all the important FDA elements necessary for registration and acceptance.


These ingredients include:

 >> FDA Medical Device Regulation: 21 C.F.R. Part 801 et seq

 >> FDA 510(k) Regulation: 21 C.F.R. section 814.9

>> U.S. FDA MAF Regulation: 21 C.F.R. section 814.9 <<

 >> FDA Medical Device Labeling: 21 C.F.R. sections 801.1 et seq

 >> FDA Color Additives: 21 C.F.R. Parts 73, 74, and 80

 >> other U.S. FDA Regulation