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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 …
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 …
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 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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Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and …
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The Importance of High-Quality Communication in the Healthcare Setting According to a Commonwealth Fund Survey, more and more physicians are at risk of burnout and health systems globally are facing a primary care crisis[1] as well as staff shortages. These have been accelerated by the Covid-19 pandemic and worsened by budget cuts and an …
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New Resource Sheds Light on FDA CDRH Regulatory Focus Device developers seeking insight into the current thinking of the FDA Center for Devices and Radiological Health as well as those pursuing a career in regulatory affairs have a new resource available. Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston …
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E-labeling: The Road to Reduced Medical Device Packaging Material In the consumer world, it’s now common practice to access product information online. For detailed instructions or information about manufacturing practices, safety advice and so on, users can scan a QR code or go to a web address, which takes them to the latest details, …
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Increasing Momentum in Medical Device Security In 2021, an employee at Ireland’s public health and social services system—the Irish Health Services Executive (HSE)—opened a spreadsheet that was sent by email. The file contained malware. After two months of free access to the network, the attackers released ransomware into the system. As the BBC reports, …
BlackHägen Design Announces Death of Founder and Human Factors Engineer Sean Hägen With deep sadness we share that Robert Sean Hägen, co-principal, founder and director of research and synthesis at BlackHägen Design passed away on February 25 after a brief illness. Hägen, who was a contributor to Medtech Intelligence, spent 28 years building BlackHägen …
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