FDA 21 CFR 820
Quality System Regulation QSR Requirements for Medical Device Manufacturers
21 CFR 820 applies to manufacturers of finished medical devices sold in the United States. This includes imported products. Only parts of the requirement may apply, depending on the class. WCH specializes in helping organizations meet the requirements of Parts 210 and 211. 21 CFR 820 can be integrated with ISO 13485, if desired.
Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing,
Packing, or Holding of Drugs
Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
A successful cGMP project will require your company’s commitment to provide resources and complete goals and homework which arise as the result of the workshops shown in the menu below. WCH cannot stress enough how important it is for your company to commit to the project in order to be successful.
The following menu is representative of the consulting services that may be provided during an implementation project.
It is also possible to request any of these services separately on an as needed basis.