What Are the Biggest Changes under EU MDR?
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements……
European regulators publish new Q&A on custom-made medical devices
The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance……
Why Risk-Based Thinking Is Essential in Medical Device Development
Many global regulatory requirements now include risk management, so medtech companies may need to revisit their quality system processes……
Traceability Requirements in EU MDR
Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical device development and post-market activities…….
The Critical Importance of Patent Protection for Diagnostics in the COVID-19 Era
Court cases have established the means for determining the patent eligibility of diagnostic methods. Does your diagnostic pass the test?……
How does HIPAA affect medical devices?
Medical device manufacturers need to understand patient privacy law and how to comply with it…….
