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Virtual Audit Planning

Virtual audits are our current situation; yes, it’s a bit out of our collective comfort zone, but it beats not performing audits at all during this time of uncertainty. Quality System compliance can still be assessed no matter the environment, with a few key changes...

FDA Refuse-to-Accept (RTA) Guidance

The Federal Food and Drug Administration has revised its refuse-to-accept (RTA) policy for 510(k) submissions to clarify its guidance after the agency noted that its staff was spending too much time drafting extensive letters requesting additional information needed...

News and Resources

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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