Compliance to ISO 13485 and FDA Quality systems regulations (21 CFR 820)

A publicly listed world’s largest medical technology company with over $ 50 Billion in market cap offering wide varieties of innovative therapies. Client operates in over 140 countries offering medical therapies in Cardiac, Vascular, Diabetic, Neurological and Musculoskeletal treatments.

The client was consolidating three structural heart valve manufacturing sites into one site. This activity required for the company to establish and demonstrate compliance to ISO 13485 and FDA Quality systems regulations (21 CFR 820) (EU and FDA). The client needed support in identifying the different elements, strategize how to demonstrate compliance, notify regulatory entities of this change, and obtain approval to market the product manufactured in the new facility.

BridgeMed solutions consultant analyzed this project, compared manufacturing end to end for impacted products, identified the manufacturing steps for which rationale can be written, identified manufacturing for which testing is necessary, generated strategies to demonstrate compliance (FDA, EU), and supported preparation of regulatory documents for submission. BridgeMed solutions consultant based on their experience, was able to perform minimal amount of testing when testing was necessary and wrote many rationale (without compromising quality) and these activities resulted in savings of ~$100,000 and led to timely approval.