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Biodegradable Polymers for Medical Device from Evonik Receive ISO 13485 Certification

Published on 2017-02-07. Author : SpecialChem

ESSEN, Germany -- Evonik’s RESOMER® brand of biodegradable polymers for medical device (MD) applications is now certified to the ISO 13485 standard, which specifically governs MD products. The bio-absorbable polymers and copolymers are used to manufacture commercial bio-resorbable implants.

RESOMER® MD Medical Products
RESOMER® MD Medical Products

ISO 13485 Compliant RESOMER® MD


A comprehensive audit conducted by DQS Medizinprodukte GmbH in late November 2016 confirmed that RESOMER® products comply with all requirements defined in ISO 13485. In particular, DQS examined Evonik’s risk management system and its quality assurance and documentation processes. The next recertification will take place in one year.

Quality and safety play a central role in the manufacture of medical devices. With this in mind, Evonik supports customers operating in this market by providing high-quality products – making a key contribution to their success.

About Evonik


Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals, operating in the Nutrition & Care, Resource Efficiency and Performance Materials segments. The company benefits from its innovative prowess and integrated technology platforms. In 2015 more than 33,500 employees generated sales of around €13.5 billion and an operating profit (adjusted EBITDA) of about €2.47 billion.

About Nutrition & Care


The Nutrition & Care segment is led by Evonik Nutrition & Care GmbH and contributes to fulfilling basic human needs. That includes applications for everyday consumer goods as well as animal nutrition and health care. This segment employed about 7,000 employees, and generated sales of around €4.9 billion in 2015.

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Source: Evonik
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