Manage episode 295017418 series 2839167
Complying with regulatory bodies is more than just producing the documentation when they ask for it. If the regulatory body is as stringent as FDA, they look for several red flags, including completeness and thoroughness of the documentation and confidence level. But speed is typically the most critical factor. Manufacturers with manual processes and fragmented systems might struggle with the speed expectations of these regulatory bodies.
In today's episode, we have our guest, Tom Rodden, who discusses the nuances of medical device manufacturing and how it differs from generalized manufacturing. He also discusses several processes and system needs that are driven by regulatory bodies such as FDA. Finally, he shares several stories where poorly maintained systems and methods may have had catastrophic results for the company.
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