The certification ISO 13485:2016 “Medical Devices – Quality Management Systems” identifies a standard for the Quality Management System specific for companies in the medical sector that includes aspects of the ISO 9001 standard and specific requirements for Medical Devices and in vitro diagnostic Medical Devices sector.

ISO 13485:2016: the best certification for medical and in vitro diagnostic Medical Devices word ISO logo
ISO 13485:2016: the best certification for medical and in vitro diagnostic Medical Devices

The ISO 13485:2016 standard ensures consistency of design, development, production, installation and supply in such a way as to make IVD and Medical Devices safe during their use.

Moreover, the ISO 13485:2016 is increasingly in demand to be the starting point of the application of the international GMP.
Indeed, the main objective of the ISO 13485:2016 is to favour international harmonization of requirements for Medical Devices and IVD.

It should be remembered that the ISO 13485:2016 standard is a precondition for obtaining the EC marking in accordance with European directives and having a conforming quality system is a prerequisite for manufacturers, critical suppliers, authorised representatives, importers and distributors as established in the MDR (EU) 2017/745 for Medical Devices and in the IVDR (EU) 2017/746 for in vitro diagnostic Medical Devices, which are regulations that will replace the current directives in the 2021 and 2022.

It can be stated that companies which decide to apply and certificate a Quality Management System for Medical Devices and IVD, in accordance with the ISO 13485:2016, demonstrate the will to continuously improve the effectiveness of their processes and they attest to their abilities to market secure and effective devices worldwide.

But to whom exactly does ISO 13485:2016 apply?

  • Companies producing third-party brand Medical Devices but which intend to start marketing the devices of their behalf in EU markets.
  • In vitro diagnostic Medical Devices (IVD) manufacturers who want to prepare for the future regulatory obligations of IVDR 2017/746 and subject to EC marking.
  • Medical Devices (MD) manufacturers who want to prepare for the future regulatory obligations of MDR 2017/745 and subject to EC marking.
  • Companies that design, manufacture and assemble Medical Devices and in vitro diagnostic Medical Devices.
  • Enterprise that distribute and market medical products.
  • Companies providing services related to Medical Devices (installation, maintenance and repair).
  • Suppliers of particular processes associated with the manufacture of Medical Devices (e.g. sterilization, storage and transport).

The advantages of the certification ISO 13485:2016

The Quality Management System and the related certification ISO 13485:2016 offer several advantages to companies in the field of Medical Devices and in vitro diagnostic Medical Devices.

In summary, for any stage of the device’s life cycle, the certified ISO 13485:2016 management system helps the company to:

  • Demonstrate the compliance with the required standards and meet customer expectations.
  • Certify the production of safer and more effective Medical Devices and IVD.
  • Optimize resources by improving risk and emergency management.
  • Improve processes in the organisation and increase the efficiency.
  • Expand marketing opportunities for Medical Devices and IVD both locally and internationally.
  • Achieve competitive advantage on the ground and globally.
  • Improve the company image with the consequent increase in stakeholder confidence.

Furthermore, in the case of manufacturers of Medical Devices and in vitro diagnostic Medical Devices, the application of the ISO 13485:2016 standard gives to the state of the art the presumption of conformity of the quality system when assessing the requirements for affixing the EC marking by a Notified Body and it allows a direct and independent audit to prepare for any market surveillance activity carried out by the Ministry of Health. 

How to obtain the ISO 13485:2016 certification?

The procedures to obtain the ISO 13485:2016 certification are rather challenging, and they require considerable investment in resources and time.

Relying on expert consultants is a valid and effective possibility to reach the result in the best possible way, optimizing time and costs.

Thanks to many years of experience, the Thema staff assists its customers in the implementation of the Quality System for Medical Devices and in vitro diagnostic Medical Devices, in accordance with regulatory requirements, providing a complete and modular service including the following activities:

  • Documentary adjustment of the system to the ISO 13485:2016 requirements;
  • Pre-audit/orientative/gap-analysis for the verification of the Quality Management System;
  • Assistance during inspections by the Certification Authority;
  • Post-visit support for the implementation of corrections and preventive actions;

Do not wait longer: Get immediately prepared for the application of the MDR and IVDR regulations, ensuring your organisation a complete and effective Quality Management System and get the results you want.
Contact us for advice! sales@thema-med.com