We launched the product as planned

Adamant Health Oy

Paulus Carpelan, CEO and Founder

Together with Kasve, we built a quality management system on schedule, which enabled us to apply for the CE mark for our medical device. The work done will pave the way for MDR requirements and accelerate our growth.

A close partnership helped keep the schedule

Adamant Health Oy was founded in August 2020. We started discussions with Kasve immediately: our goal was to have the CE mark on our medical device by the end of May 2021. We needed help to get our software product ready for registration, which required the implementation of a quality management system and the creation of product documentation.

Initially, we did a preliminary study and a roadmap with Kasve about what kind of things we need. Based on this, we made a plan and phased it so that before the entry into force of the MDR, our device will be CE marked.

Registration and CE marking are an essential part of working in this field and are required in order for a medical device to be placed on the market. For Startup, the CE mark is also a way to get to the next stage as a company, ie to move from pure product development to doing business.

A credible conversation can be held with customers when the product or device can be used in clinical use, allowing customers to try and pilot the product. Without the CE marking, this would only be possible as part of a licensed research process.

We wanted an outside partner to support us for practical reasons. We did have experience with quality management systems and making a medical device, but things have changed since I was last involved in a similar job, and it’s a different matter to know all the sections correctly and answer all the questions correctly.

Due to the tight schedule and as a start-up company, we also felt that it is almost impossible to find a suitable person to join the company. We wanted a partner who would know exactly all the requirements and know the necessary instructions.

We received help with configuring and automating the development environment

We received extensive support from Kasve at different stages of the project and also accumulated our own expertise. I feel that we were on the same wavelength and were able to resolve situations and take the project forward smoothly.

Kasve played a big role in building the quality management system: they wrote us the quality system documents for comment, and supplemented them based on our discussions. For a few-person company, this was the right method: we specifically wanted a partner who would do more than just throw standard bases for us to complete.

Our roles in compiling the technical file were the opposite: Kasve commented on our writings and felt that they were in line with the requirements. As product experts, this was natural for us.

In addition, Kasve helped us build a development environment on top of the Atlassian platform. Kasve experts configure and automate the environment so that the quality management system works seamlessly with the tool. For a small organization, it is essential that things like reporting are automated and work according to the process.

We worked as a team and our cooperation went well. We had a shared idea of needs and goals and where the bar is going: what to do now and what to do later. We met weekly and also monitored the progress of the project using the Jira tool.

Our main goal was the CE mark and we achieved that. We will continue to work on our Quality Management System as EU and national legislation and guidelines are completed. Through the Kasves Health Tech TopExpert training program, we also found a regulatory expert who will be responsible for regulatory and quality management issues in the future.

Kasve had a credible offer and a team

Kasve was selected as a partner primarily on the basis of a tender: Kasve had a credible offer and a credible team. As a software company, it was very important to us that Kasve had the expertise to provide software and especially the Atlassian environment. I also had previous experience with Kasve and contacts with the company.

We are very pleased with the way the project was handled. Kasve experts knew their stuff and were able to get answers when they weren’t obvious. I can recommend Kasve’s services to others as well.

Adamant Health Oy

Adamant Health Oy is a health technology  startup company, which is based on more than 15 years of research conducted by Saara Rissanen at the University of Eastern Finland and provides measurement and analysis services related to movement disorders. The company provides technology for long-term and accurate measurement that provides a good view of a patient’s symptoms and enables a better quality of life through good care. Adamant Health’s next goals are first-time customers, patient impact validation research, and increasing automation and scalability. At the same time, product development and the development of the quality management system continue. Read more about Adamant Health Oy at https://www.adamanthealth.com/