![]() ![]() The new edition of the ISO standard was published on March 1, concluding almost five years of intense discussion and development by experts around the world to improve and update the standard with new European requirements and other international regulatory changes, implemented since its previous revision in Organizations complying with this standard, such as medical devices manufacturers, as well as suppliers and external parties that provide products or services to manufacturers, will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients and users.
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