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European notified body TÜV SÜD said the EU medical device regulation finalized May 5 includes specific clinical requirements that are not consistent with the MEDDEV 2.7/1 Rev. 4 guidance on clinical evaluations for device manufacturers and notified bodies. Read More
Japan’s Pharmaceuticals and Medical Devices Agency has been ramping up its regulatory training activities with overseas regulators, and it inviting international regulators to a medical device seminar in Tokyo, Nov. 6-10. 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