Qualification & Validation

Genesis Medical Plastics helps bring your medical device to market by providing qualification and validation services. FDA 21 CFR part 820 requires process validation when the required characteristics of a device cannot be fully verified by subsequent inspection and testing after manufacturing.  This often comes into consideration when material properties beyond composition are required for a medical device to perform in a safe and effective manner.

Genesis Medical Plastics has the experience and systems needed to provide the objective evidence required for GMP process validation which includes: Master Validation Plans, Installation Qualifications, Operational Qualifications, and Performance Qualifications.


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