Specification and Adoption of an ISO 13485 Compliant Quality Management System in a Medical Device Manufacturing Start-up

Abstract

Due to the safety and health related risks in using medical devices, they are regulated in most parts of the world. In the European Union medical devices regulation is undergoing a major redesign as of the writing of this thesis. Medical Device Regulation is the new regulation and it is entering into force May 25th 2020. By that date all medical devices in the market need to comply to the Medical Device Regulation. The current regulation is stated in the Medical Device Directive. The EU regulation classifies devices based on their functionality and risks in using the medical device. Most standalone software medical devices that are classified as class I in the Medical Device Directive will move up to class IIa, IIb or III in the Medical Device Regulation. The compliance to EU medical device regulation is proven with the quality management system documentation. For class I medical devices neither the Medical Device Directive or the Medical Device Regulation require a standardized quality management system and class I medical device manufacturers do not need an external audit prior to releasing the product to the market. For class IIa, IIb and III the Medical Device Regulation requires an external audit of the quality management system by an EU notified body prior to giving the medical device a CE-marking. Without the CE- marking medical devices cannot be placed in the market. The European Commission has worked together with international standardization organizations to publish harmonized standards that the manufacturers of medical devices can apply to their processes to reach compliance with the regulation. ISO 13485:2016 is the quality management system harmonized standard. This thesis studies the quality management system of KAMU Asthma, a standalone software medical device developed by KAMU Health Oy and classified as a Class I medical device under the Medical Device Directive. The problem is that KAMU Asthma will be classified as at least a class IIa medical device under the Medical Device Regulation and the current quality management system that is used for development of KAMU Asthma does not fulfill the requirements for a class IIa and up medical device classes. This thesis conducted a gap analysis to figure what parts of the current KAMU Asthma quality management system need updating to reach the require- ments of an ISO 13485 compliant quality management system and thus become compliant with the Medical Device Regulation. The documentation of the current quality management system was inspected and compared with the documentation requirements for an ISO 13485 compliant quality management system. ISO 13485 documentation requirements were listed on a document checklist and the checklist was filled with the applicable documentation of the current quality man- agement system. As the result of this thesis the rest of the ISO 13485 requirements can be fulfilled by implementing the rest of the requirements found on the ISO 13485 documentation checklist.