Resources

The International Medical Device Regulation Forum (IMDRF) recently published updated cybersecurity guidance for the medical device industry. The medical device cybersecurity working groups at IMDRF have been busy lately, publishing...

The global pandemic and continued supply chain disruptions have prompted many U.S. pharmaceutical and medical device manufacturers to reassess their reliance on offshore production. As organizations place greater emphasis on...

Why has product launch become more complex after the pandemic & how have the "roots of compliance" changed the EU regulatory environment? In this sound bite from RCA Radio, host...

What should you do if you are having trouble executing your design protocols? Listen to this highlight from RCA Radio where Walter Mason explains what needs to be done if...

Medical Device Regulations Changes coming with Brexit. Listen to this highlight from RCA Radio where Seyed Khorashahi breaks down the UK’s Medical Device Regulations resulting from Brexit and choosing not...

The application date of May 26, 2022, for the EU In-Vitro Diagnostic Medical Devices Regulation (2017/746) (IVDR) has created a huge challenge for IVD medical device firms planning to introduce...