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Validation for software in regard to management systems for medical products according to ISO 13485

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EN ISO 13485 was updated and published in early 2016. The standard is very important to manufacturers regarding the certification of their management and quality assurance system.

The updated version focuses especially on the requirements of software being used in the field of the production of medical products. Those requirements have been increased compared to the previous version of EN ISO 13485, leading to almost similar requirements as the comparable international standards of the US FDA or the Brazilian ANVISA.

The standard will become effective November 2018, but manufacturers of medical products would do well to cope with the requirements early on. Agreements, especially with suppliers of hard- or software IT as well as development contracts must be amended (see Michael Stöcker, Validierung auch für Software in Medizin, kaufmännischer Bereich und Technik, 4/2016, S. 94 f.).

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