The FDA website states that Process Validation means establishing (by objective evidence) that a process consistently produces a result or product meeting its predetermined specification.
As medical device contract manufacturer, accountability is part of our culture here at MME group. We have constructed our ISO system to follow and conform to the 21 CFR Part 820 requirements, while keeping your company’s requirements under consideration.
We combine your own quality system requirements with our custom tiered system, using our rigorous advanced planning and risk analysis to determine the best validation plans for your products. This results in a superior level of attention to detail regarding design, production, quality controls and documentation.
As an FDA registered Contract Manufacturer with medical device validation (registration number 300653510) we maintain a quality system compliant to 21 CFR Part 820. We are excited to assist in the manufacturing of your FDA regulated products.