Terveystalo to become a manufacturer of software-based medical devices

Terveystalo press release 12 August 2021

Terveystalo has been awarded the ISO 13485 quality system certificate as the first health service provider in Finland. With the certification, Terveystalo will become a manufacturer, distributor, seller and marketer of software-based medical devices.

“Medical science guides all of our operations and we are now at the forefront of software development, which is driven by medicine. For us, the certification is a strategic capability that enables the development of intelligent software for healthcare. With even smarter software, we can, among other things, increase the efficiency and the level of self-service within healthcare services,” comments Ilari Richardt, Terveystalo's Director of Digital Development.

“In practice, software development under ISO 13485 certification can mean, for example, smarter customer care management automatically from the beginning to the end of the care path, or effective identification of health risks and targeting treatment to those individuals most likely to benefit from it based on data analysis,” Richardt continues.

ISO 13485 is an international quality system standard for the design, manufacture, distribution, sales and marketing of healthcare equipment, software and supplies. With the EU Medical Device Regulation (MDR), the requirement for a certified ISO 13485 quality system applies to an increasing number of medical software manufacturers.

The sales and marketing of medical devices requires the CE marking of the product. The prerequisite for obtaining the CE mark is that the product has been designed and manufactured in accordance with the requirements of the ISO 13485 quality system and meets, among other things, the requirements of the Medical Device Regulation. The awarded certificate illustrates that Terveystalo's processes meet these requirements set for the medical device manufacturer.

“In medicine, effectiveness, or patient benefit, arises from doing the right things right. Software development in accordance with the new quality system further enhances patient benefit, as the clinical validation and evaluation required by the quality system ensures that the right, customer value-adding things are done in software development. Other elements, such as the assessment of benefits and risks, the requirement for careful documentation, and the product lifecycle management, drive things to be done in a high-quality and standardized manner,” says Simo Taimela, Terveystalo's Chief Epidemiologist.

For further information, please contact:
Ilari Richardt, Director of Digital Development, +358 415 356 312
Simo Taimela, Chief Epidemiologist, +358 405 750 757

Terveystalo in brief 

Terveystalo is Finland's largest health service company in terms of revenue and network, with the aim of empowering lifelong health and well-being and building a healthier society. The company provides comprehensive well-being, primary care and specialist care services to corporate and private customers, as well as the public sector. Terveystalo's digital appointment serves are available 24/7, regardless of time and place. In addition, the company offers health and well-being services in more than 300 locations throughout Finland.

In 2020, Terveystalo had 1.2 million individual customers. Some 6.9 million customer visits were made, of which more than a quarter took place in remote channels. Terveystalo employs more than 13,000 health and well-being professionals.