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Think about package validation early in product development

Medical devices are often complicated and expensive machinery that must be treated with care. People’s lives may depend on these devices functioning properly, so why risk damaging the devices with shoddy packaging? Medical device testing is a rigorous and complex...

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RAPS Euro Convergence 2020 Summary

RAPS Euro Convergence 2020 Summary

The 2020 conference, or “convergence,” of European regulatory professionals that was originally to be held in October in Brussels instead took place virtually due to the pandemic. Even though it was conducted entirely online, the convergence covered a lot of...

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Person Responsible for Regulatory Compliance

Person Responsible for Regulatory Compliance

As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC). This individual (or...

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