Medical Innovation Exchange

MedTech

Clock Starts for New EU MDR Transition Dates

Clock Starts for New EU MDR Transition Dates     An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European Union on March 20. Producers of medical devices will now have until December 31, 2027, for …

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Expand Your Regulatory Intelligence

Expand Your Regulatory Intelligence     In an increasingly digital world, medical device regulators and regulatory professionals have more information than ever to help them identify adverse events and new indications. Combined with shifting U.S. and global regulatory requirements, the task of staying abreast of new requirements and data sources is becoming a Herculean task. On …

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How a Comprehensive UX Approach Brings Value to the Design Process

How a Comprehensive UX Approach Brings Value to the Design Process     UX design processes are constantly evolving as the industry continues to embrace IoT (Internet of Things) technologies. With this evolution comes a need to focus on improving UX (User Experience) protocols in the design of medical devices. UX, driven by human factors engineering …

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What You Need To Know About FDA Remote Medical Device Inspections

What You Need To Know About FDA Remote Medical Device Inspections     Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible. The remote inspection argument was especially compelling in the throes of Covid-19, which …

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