ISO 13485 -standard

The ISO 13485 standard sets a frame for a quality management system for medical devices.

ISO 13485 – the most important standard for medical devices

ISO 13485:2016 standard sets a frame for a quality management system of an organization involved in the life cycle of medical devices. The standard focuses on the requirements that an organization must meet to indicate that the medical device the organization manufactures and and/or its other activities comply with the requirements of the relevant regulations and the customer needs.

The quality management system requirements defined in the standard support the product’s technical, safety and performance requirements, which arise from customer needs and legal requirements. ISO 13485 contains requirements for quality management systems and its related document control, management, managements responsibility, resource management, product realization as well as measurement, analysis, and improvement.

Certification of ISO 13485 quality management system

Organizations involved in the medical device operator chain (manufacturers, distributors, and subcontractors) can certify their quality management system if they wish, i.e., get it evaluated by an external party and have a certificate issued by it. For manufacturers of medical devices, the certification of the quality management system is part of the conformity assessment carried out by the notified body according to the regulations. A certified, ISO 13485 standard compliant quality management system is a requirement – set by EU legislation for the manufacturers of IIa, IIb and III class devices (MDR) or B, C, D (IVDR) class devices.

EN ISO 13485:2016 harmonized with EU legislation (MDR and IVDR) 

The ISO 13485:2016 standard is harmonized with the EU legislation on medical devices and in vitro diagnostic medical devices, which means that by following the standard, the organization meets the specific requirements of the legislation. FDA is also harmonizing its requirements to comply with the ISO 13485:2016 standard.

Kasve’s ISO 13485 services for our customers’ needs

Kasve’s experts have been involved in developing, updating, and auditing several quality management systems of medical device manufacturers and distributors to ensure compliance with the ISO 13485 standard. Your organization will get support in defining and developing, in identifying and describing the processes, in development activities and in auditing of your quality management system. In addition, we help you to consider the requirements of local legislation as part of the processes of the quality management system. Kasve’s experts are qualified to perform audits on ISO 13485 compliant activities (lead auditor and internal auditor qualifications).

The QAiRA tool developed by Kasve, which is software for managing health technology regulations and quality management, also helps in the development of the quality management system, internal auditing, and preparation for certification. From QAiRA, you can also get the reports produced by the ISO 13485:2016 audit tool conveniently in pdf format.

Check out our references related to the ISO 13485 standard

Kustannus Oy Duodecim

Read how together with Kasve, Kustannus Oy Duodecim has built a Quality Management System in accordance with the ISO 13485 standard, and is developing software product in accordance with the IEC 62304 standard.


Read how Kasve helped Cerenion to build up ISO 13485:2016 QMS that, for example, enhances company’s R&D activities, risk management and training of personnel. Kasve also participated into software development documentation.

Buddy Healthcare

Read how Kasve supported Buddy Healthcare in building up the EN ISO 13485 compliant Quality Management System and developed company’s internal auditing.

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Other standards

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