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QM Certification

The demand for a voluntary certification, according to QM standards, has increased during the last several years. This holds especially true for suppliers of components, semi-finished products, as well as for subcontractors and service providers for the medical device industry.  A certificate according to EN ISO 13485, issued by a registrar which is recognized as a Notified Body, is a real benefit.  Usually manufactures consider the availability of a certificate according to EN ISO 13485 as evident, and the frequency of supplier audits are significantly decreased by the manufacturers’ Notified Bodies. In parallel with EN ISO 13485 the compliance with specific technical standards (e. g. validation standards for sterilization procedures) may be confirmed.