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Pre-Sub Process Recommendations

A Pre-Submission (or Q-Submission) is a structured process for developing interactions between medical device manufacturers and FDA about a myriad of topics that ultimately point to future applications for approval or clearance, prior to the IDE, 510(k), PMA, or De...

Risk Management Series – Part 4: Key Terms

Introduction Before diving into the best practices for conducting a risk assessment, it’s important to clarify some terminology. ISO 14971:2019 (the Standard) and TR 24971 (the Guidance) provide helpful definitions and examples, but even with that, the use of some...

New and Important Distributor Requirements Under EU MDR

European Union (EU) medical device regulations (EU MDR) have significantly increased the requirements for distributors. If you are currently a distributor of medical devices in the EU, or are considering doing so, it is important that you understand these new...

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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