Fighting Medical Regulatory Bureaucracy with PDM

Oct 21, 2015 4:17:56 PM / by Synergis Software posted in Engineering document management, Medicametrix, compliance, customer story, EDM, case study, audit trail, PDM, Product data management, Technologies

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MedicaMetrix is a US-based startup in the medical devices industry. It is an industry notorious for chewing up and spitting out small companies like a monster finding bad grapes in a vineyard. Founder-CEO Christopher LaFarge says investors in his industry look for leaders “who will run through brick walls head first” among other attributes. “Somehow, they are going to end up in the market with something that makes money,” no matter what it takes.

One of the frustrations in developing new medical devices is the “alphanumeric soup” of regulatory and compliance agencies. There is the FDA in the US, and an equivalent agency for European Union nations. Each agency wants an incredible amount of documentation, presented their way. While there is some overlap, they both want schematics and circuit board designs, CAD file prints of the product, and all the accompanying documentation generated in word processing, spreadsheets, accounting, and other software presented in a specific way.

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