USA- 21 CFR Part 820
Medical devices are considered in a “regulated space” and are driven by regulations – laws that must be followed in order to put your device in the market under the jurisdiction of the local regulatory authority.
In the US, this is the Food and Drug administration.
The regulation is the Quality System Regulation or the Code of Federal Regulations, Title 21, Part 820 (aka 21 CFR 820).
The regulations cited in the QSR regarding validation are all follows:
- 820.30(g) (product): Each manufacturer shall establish and maintain procedures for validating the device design.
- 820.70(i) (process): When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.
- 820.75(i) (process): Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.