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Quality . ProLung

Mar 27, 2018 . The ProLung Test has obtained CE Mark which permits the product to be sold . under a quality management system (QMS) that is ISO 13485 certified. Compliance with the ISO 13485 standard, for medical device quality.

CE marking - European Commission

CE marking - Internal Market, Industry, Entrepreneurship and SMEs. . Please note that a CE marking does not indicate that a product have been approved as.

CE marking - Wikipedia

CE marking is a certification mark that indicates conformity with health, safety, and . Retailers sometimes refer tos "CE approved", but the mark does not actually signify approval. . Module E Product quality assurance. . Article 1 states the Directive covers "any equipment designed for use with a voltage rating.

ISO and CE certified - Diving Un International

ISO and CE certified. Diving Un International, Inc., the world's leader in designing and manufacturing drysuits, has had the highest quality standards for its.

ISO 13485 How to use it to get the medical device CE Mark

Oct 12, 2017 . How to use ISO 13485 to get your devices approved for CE Marking . ISO 13485 is aligned with European medical device directives; therefore, . A Quality Management System based on ISO 13485 helps to meet most of.