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ISO 13485:2016 Certification

Medical Device component manufactures, finished good manufactures, Medical Software developers, Medical Device designers and Developers and pharmaceutical suppliers interested in enjoying worldwide presence has to prove there devices are manufactured under certain auditable standards which means it’s safe and effective. ISO 13485:2016 Certification is a solution for this issue!

Regulatory authorities in most major markets like European Union, United States, Canada, Japan, and Taiwan require, or strongly prefer, that manufacturers marketing medical devices in their countries have a third-party audited and certified Medical Device Quality Management System in place. An ISO 13485:2016 compliant system expedites access into those countries that require it.

ISO 13485 is an internationally recognized standard of quality, which articulates the stringent requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. Based on better-known ISO 9001 standards, ISO 13485 requires heightened attention to the regulatory requirements associated with the design, development and manufacture of medical devices. Proven Process first earned its ISO 13485 certification in 2002.

The standard does not provide a direct solution to design quality. However it helps to create a framework which enables the use of various solution models depending on the one hand on manufacturer’s size, the complexity of the products and the potential risks and on the other the quality targets set by manufacturers themselves with regard to both their own operations and the devices.

Benefits of ISO 13485 Certificate

  • Provides confidence of quality risk management and good manufacturing practices within the medical device supply chain throughout the medical device product life cycle
  • Enables your organization to prepare for product-to-market regulatory requirements for the medical device markets of Europe, Australia, Asia and all major developed as well as emerging markets
  • Provides confidence that best practice validation and GMP have been implemented and evaluated
  • Provides assurance that appropriate regulatory requirements are implemented within your organizational procedures

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