We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The letter urges the leaders to adopt the EU’s new regulations covering medical devices and IVDs to encourage global harmonization and to keep EU-wide networks strong. Read More
The UK’s Medicines and Healthcare products Regulatory Agency plans on issuing guidance on co-developing medicines and IVDs in the near future. Read More
The UK’s Medicines and Healthcare products Regulatory Agency published new guidance on human factors and usability engineering for medical device manufacturers — pulling back the curtain on the UK’s regulatory structure, and showing how various usability engineering strategies stack up against each other. Read More
Medical device manufacturers with products in China should check their current product portfolios against a new device catalog released by China’s Food and Drug Administration to develop transitional plans if any of their devices will be reclassified. Read More
The FDA added the UL 2900 cybersecurity standard for medical devices to its list of recognized standards. The standard covers assessments of network-connectable devices for malware, software limitations and vulnerabilities. Read More