ISO 13485, the passport to assured safety of medical devices

ISO 13485, the passport to assured safety of medical devices

Recently revised, international voluntary standard ISO 13485 is a certifiable standard. Certification is possible for organizations specializing in medical devices whose quality management system is deemed to conform to the standard or for organizations forming part of the supply chain. Examples of companies already holding the certification are Russian equipment supplier MSM Medimpex and French startup SLS France, commented on here by their respective representatives Quality Manager Oleg Levchenko and CEO Axel Dubois.

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