Medical Device Process Validation is vital in medical implant and device manufacturing to ensure consistently high quality, OEM specifications and legal compliance and to risk mitigation for the implant recipient and for the OEM. There are 3 stages of qualifications: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Norman Noble typically runs three consecutive lots to satisfy the PQ stage of validation.
The FDA mandates when validation is required: “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. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.” (21CFR820.75, FDA Code of Federal Regulations). Also, the FDA broadly outlines its requirements for process validation procedures and documentation in 21CFR820.75 of the Code of Federal Regulations.
FDA regulations surrounding process validation are mandatory and compliance is a legal obligation. However, the value of process validation goes beyond satisfying the letter of the law. At Norman Noble, quality is mandatory. Our dedicated team of validation engineers write a validation strategy based on each project. Norman Noble ensures the OEM, with a high level of confidence, that its process validation will result in manufacturing processes that produce the same exact quality part each and every time.