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CE Mark Certification in duchy

Submitted by juiuu on Fri, 04/26/2024 - 21:57

The Duchy must get CE mark certification for goods intended for sale in the European Economic Area (EEA), attesting to compliance with essential environmental, health, and safety standards. Getting a CE marking is a lengthy process that includes technical file documentation, manufacturer certification of conformance, and conformity evaluation. All products, including electrical appliances and medical equipment, must pass rigorous testing and evaluation processes to ensure they comply with EU standards.

ISO 13485 Certification in duchy

Submitted by juiuu on Thu, 04/25/2024 - 02:12

An international standard that outlines specifications for a quality management system (QMS) in the medical device business is ISO 13485 Certification in Duchy. Its goal is to guarantee that medical devices that are safe for their intended use are consistently developed, produced, installed, and delivered. Organizations must set up and keep up a quality management system suitable for the size and scope of their business in order to comply with ISO 13485 criteria.

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