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Devicemakers are closely watching the EMA and the U.K.’s Medicines and Healthcare products Regulatory Agency for assurances on how conformity assessments will unfold under the new EU regulations. With fewer notified bodies in the EU, and the added complication of Brexit, the next steps remain uncertain. Qserve Group Executive Director Gert Bos — an auditor and former head of a notified body — spoke with IDDM on the changing environment and how devicemakers can plan for upcoming conformity assessments. Read More
The Dutch Minister of Health signed the agreement in late June, in collaboration with healthcare providers and device distributors and manufacturers. Read More
New Zealand’s Ministry of Health released new standards that will ensure all medical devices are properly named and identified for clinical and supply chain purposes in the country. Read More
The Congressional Budget Office officially scored the Senate package to reauthorize the FDA’s user fee agreements with the medical device and… Read More