ISO 13485 Quality Management System Certification for Medical Devices

The ISO 13485:2016 standard specifies the requirements for a Quality Management System under which a company demonstrates its ability to provide Medical Devices and related services, which comply with the requirements of the applicable Regulatory Framework, of the Legislation and the requirements of its customers.

The ISO 13485 applies to any company involved in one or more stages of the life cycle of a Medical Device or Service, including design, development,production, storage, distribution, installation or maintenance.

Current version ISO 13485:2016

To ISO 13485 standard has been revised and the current version is ISO 13485:2016, on the basis of which all certificates are now issued. The transition from the previous version was completed in February 2019.

What NOVITAS can do for you

The company NOVITAS a member of SPIN GROUP, has personnel with expertise and many years of experience in the development, implementation and certification of management systems for businesses engaged in the production (OEM & OBL) and distribution of medical devices.

• We adapt the old system to the new requirements in a way that ensures a smooth transition, without disrupting the existing state of affairs.
• Thanks to their many years of experience, the personnel of NOVITAS are familiar with the operating environment of businesses producing medical devices, and thus NOVITAS can offer flexible, effective solutions at a reasonable cost.
• We provide the necessary information and training on the implementation of the new system, so that you can take full advantage of its new benefits.
• The NOVITAS has already implemented successfully, projects for the development and and transition of ISO 13485 management systems in companies (OEM & OBL companies) producing and and distributing medical devices in Greece, Germany, Russia, Ukraine and Cyprus.
• Our clients always remain fully satisfied with the services and the support we provide, which is why we maintain long-term partnerships.
• Ανάπτυξη και αναβάθμιση Συστήματος Διαχείρισης Ποιότητας κατά ISO 13485:2016 συμπεριλαμβανομένης της τροποποίησης A11 (EN ISO 13485:2016/A11:2021), ώστε το σύστημά σας να είναι πλήρως εναρμονισμένο με τις απαιτήσεις των Κανονισμών MDR 745/2017 και IVDR 746/2017.