21 CFR Part 820 QS Regulation for Medical Device Companies
If you manufacture a medical device, the FDA will require that your quality system meet the Quality Management System Regulations of 21 CFR Part 820, which outlines the current Good Manufacturing Processes (cGMP) for medical devices. The FDA enforces QSRs as part of the Safe Medical Devices Act to ensure that medical devices consistently meet specifications.
To be compliant with FDA 21 CFR Part 820, you must:
- Create a Quality Management System, which addresses the:
- risks presented by the device
- complexity of the device and its manufacturing processes
- size and complexity of your organization
- Establish controls necessary for your operation, which may include:
- Design controls
- Equipment and facility controls
- Production & process controls
- Records, documents & change controls
- Develop human factors related to the use of your product
MethodSense is experienced in FDA GMP (good manufacturing processes) consulting and ISO quality system regulations for manufacturers in the US, Canada and Europe.