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• #ISO 13485 QUALITY MANAGEMENT SYSTEM ISO#

#ISO 13485 QUALITY MANAGEMENT SYSTEM ISO#

facilitate the access to global market, as the ISO standards are internationally recognized and, in some extra-EU countries, necessary.monitor safety, efficiency and performance of the entire supply and distribution chain.identify an efficient method for managing business processes, reducing waste of time and resources.Quality Management System certification according to ISO 13485:2016 requirements allows to: QMS certification according to ISO 13485:2016 has a double advantage: on the one hand, it provides a practical tool to face the conformity assessment process of the product to the regulations, on the other hand, it shows the company's commitment to quality and safetyof their medical devices.

What benefits does the QMS certification according to ISO 13485:2016 provide?

Why certify your QMS, according to ISO 13485?Ĭertifying a product according to the scheme established by the ISO 13485:2016 enables manufacturers to demonstrate their ability to provide medical devices and related services that meet market standards and applicable regulatory requirements. It involves aspects of the ISO 9001 standard and additional requirements specific to the medical field, and it has been harmonized in compliance with the relevant European Directives - Medical Devices, In Vitro Diagnostic Devices and Active Implantable Devices. The ISO 13485 standard " Medical devices - Quality Management Systems - Requirements for regulatory purposes" provides specific internationally recognized requirements to certify the Quality Management System for medical device companies.