Kasve brought us enourmous Quality Management know-how
Kustannus Oy Duodecim
Eija Kutinlahti, Quality control manager
Together with Kasve, we have built our Quality Management System in accordance with the ISO 13485 standard, and we are developing our software product in accordance with the IEC 62304 standard. In this way, we will update our quality management to the level required by the new regulation, and our business can continue at its former scale.
Our collaboration with Kasve began in 2018, when we found out that the new Medical Devices Regulation (MDR) required us to build a quality management system. The product classifications of the new regulation are stricter, and mostly all medical software will be upgraded to Class IIa, requiring a quality management system. Our product classification will also be IIa in the future, although our products will not change.
I think it is a competitive advantage that our products are medical devices and we can rely on their patient safety. Kustannus Oy Duodecim is owned by the Finnish Medical Association Duodecim. We provide services to citizens and professionals, including the Omaolo service for symptom assessments and the EBMEDS Decision Support service, which is used by healthcare professionals as part of the patient diagnosis and treatment process. If we would not meet the requirements of the MDR, important tools could not be used by both professionals and citizens. For our part, a big slice of our turnover would disappear.
We got support to embrace the Quality Manager role
As an organization, we did not have the competence to set up a quality management system independently. We wanted consulting assistance in building up a quality management system and embracing the responsibilities of a quality manager. The MDR requires that the organization has a person who meets certain quality management requirements. I switched to the position of Quality Manager without a quality management background, and as part of the project, Kasve trained me for my new duties.
In the early phase, our cooperation with Kasve was really close, and as the project progressed, the work done was adapted to the ongoing phase. With the help of repetitive meetings, we have brought everyone’s expertise forward. The firstgoeal has now been achieved: we have a certified quality management system with good results that guides our operations.
QAiRA keeps us up-to-date
We also have a QAiRA tool developed by Kasve in use, which allows me to easily stay up-to-date on changed legislation, regulations and guidelines. In the future, we will also use it to support internal auditing and in preparation for external audits.
IEC 62304 standard brings new competence to product owners
In the daily life of the personnel, the quality management system is visible to key persons such as product owners and the technical team. MDR also sets new requirements for the product lifecycle, and as part of the project, we are bringing our product development process in line with the software lifecycle standard, the IEC 62304. From Kasve, Ville has helped us to apply the standard to our operations, and for that an external audit is soon ahead of us.
With the help of Kasve, product owners have also accumulated their know-how, e.g. Using the Jira and Confluence tools. We are currently working with Kasve to refine the system and ensure that we meet all MDR requirements.
Kasve is a comprehensive and high-quality companion
The cooperation with Kasve has gone well, and for my own development, Nina has been a very important companion for me. Our personalities have met nicely, and I have learned tremendously.
Along the way, we have received quick answers to our questions and have been able to trust the information we have received. The pre-prepared templates from Kasve have been a big help in preparing the documentation and have helped to outline the system as a whole. Without them, getting started would have been challenging. In addition, the fact that Nina participated in the first audit provided us assurance that the audit would be conducted in good results.
As an operator focused on our industry, Kasve is certainly one of the best in Finland: the company’s expertise in medical devices is good and diverse, and our project has been implemented with high quality. I have seen Kasve, a relatively small size company, as a strength compared to a large consulting house: I feel that the collaboration has been smoother with a smaller team. I can recommend Kasve especially to a company that is starting to build a quality management system for its medical device.
Kustannus Oy Duodecim
Kustannus Oy Duodecim is a traditional operator that offers products to citizens and healthcare professionals that promote health and medical care. The company’s products include e.g. STAR Health Check, EBMEDS The Evidence-Based Medicine Electronic Decision Support, health benefit analysis and symptom checkers. In addition, the company’s products include Terveyskirjasto.fi, Terveysportti and Oppiportti.
The Finnish Medical Association and Kustannus Oy Duodecim work closely with domestic and international organizations specializing in evidence-based medicine. Well-known partners include e.g. the Cochrane community, which produces systematic literature reviews, the GRADE research community, and the international treatment recommendation organization GIN. Read more: https://www.duodecim.fi/kustannus/
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