![]() ![]() Manufacturers of medical devices are expected to comply with a more demanding regulatory environment as effectively reducing risks, as low as possible for patients and bystanders. New technology enables new effective diagnostic and therapeutic methods as well as new challenges in controlling new hazards. This standard is since December 2019 also on FDAs list of so called “Recognized Consensus Standards” New Regulatory Environment ![]() During this one-day course you will get a good understanding of the key requirements that shall be fulfilled to establish and maintain a risk management system in compliance with 14971:2019 and its relation to EU and US Medical Device regulations.
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