Adhesys Medical EN ISO 13485 Certification

Adhesys Medical is now EN ISO 13485 certified

On 7. September 2016 Adhesys Medical obtains the EN ISO 13485 certification for its quality management system. The notified body, ecm Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH confirms that Adhesys Medical has established and implemented a Quality Management System according to EN ISO 13485:2012 for the development, manufacturing and marketing of medical devices for wound care, especially medical adhesives.

“We are very proud of this significant milestone that shows we have a quality management system in place that complies with international quality standards and enables us to provide high quality products to our customers” says Steve Gotzen, Technical Director and Quality Management Representative at Adhesys Medical. The certification paves the way for market launch of the company’s first product, a Topical Skin Adhesive.

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