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What You Need to Know About GDPR

If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data...

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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