Design Control & Risk Management

Helping Medical Device Startups Break Into the UK, EU, USA & GCC Markets

As part of managing your entire submissions, Simplimedica can ensure your design plan is in place and followed. We can project manage all elements of design & development, including inputs & outputs and ensure all verification and validation activities take place either with your capabilities of testing or we can use our strong network of providers, laboratories, and test facilities to ensure your physical, biological and chemical testing has satisfied the correct regulatory requirements to ensure your devices has met the safety characteristics needed.

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25+ Years of Regulatory Experience

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