Chemical Compliance Requirements for EU MDR and IVDR

Is your medical device or diagnostic in compliance with this small, but essential, sub-section?……

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……

Companies, docs alarmed by proposed 510(k) rollback

Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process……

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……

FDA says to limit mask decontamination to 4 cycles

Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times……

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…….

Can Design Controls Accelerate Medical Innovation?

Response to the pandemic fast-tracked the pace of medtech innovation. In the future, can a human-centered iterative approach to design controls help maintain that momentum?……

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…….

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