Triconsult, a new member company of CleverHealth Network, helps health sector organisations understand requirements relating to medical devices, artificial intelligence, data protection and quality management. One of the company’s founders, consulting director Mikko Rotonen, is very familiar with the CHN ecosystem, having been involved already in its establishment at HUS Helsinki University Hospital in his role as IT development director.
Triconsult has joined the CleverHealth Network ecosystem to strengthen the expertise of its member companies, particularly in regulation at EU and national level, R&D or medical devices, certification and quality management systems. The company has deep expertise in the practical interpretation of regulations and standards regarding medical devices, AI solutions and secure information systems. It closely monitors the sector’s continually changing regulations so that its client companies do not have to do so themselves.
Triconsult’s consulting director Mikko Rotonen recently retired from HUS Helsinki University Hospital, where he was also involved in establishing the CHN ecosystem. His long experience at HUS of health data, AI-assisted medicall software and demanding quality management systems provides Triconsult with a strong foundation for supporting companies developing solutions for healthcare needs.
Mikko Rotonen holds certification qualifications for the following ISO standards:
- ISO 9001:2015 – Quality management (latest version coming in 2026)
- ISO 13485:2016 – Quality management system for the lifecycle management of medical devices (QMS)
- ISO 27001:2023 – Information security management system (ISMS)
- ISO 27701:2025 – Privacy information management system (PIMS)
- ISO 42001:2026 – Artificial intelligence management system (AIMS)
Help for interpreting requirements and certification pathways
Triconsult provides expert services to companies and also many actors in the public sector, such as wellbeing services counties, that require support in building quality management systems, carrying out pre-audits, preparing for certification or interpreting regulatory requirements. The company actively follows guidance issued by EU-level and national authorities, including regulations concerning medical devices, artificial intelligence, data protection and information security.
The regulatory landscape and keeping up with its changes is particularly challenging for small and medium-sized enterprises, which may not have their own quality management or regulatory specialists. Triconsult can help e.g. to assess when a solution under development meets the definition of a medical device, when it may constitute a high-risk AI system, and what requirements must be met in order to place a product on the EU market.
Practical support for SMEs
Triconsult offers companies practical support in interpreting requirements, lead audit expertise and assistance in understanding manufacturers’ responsibilities. The company helps, among other things, with risk assessment, documenting requirements and categorising products when solutions are being developed for the needs of wellbeing services counties, hospitals or international markets.
According to Rotonen, Triconsult joined CHN because it wants to support the partner companies at a time when there are numerous regulations, standards and authority guidelines, all of which are constantly evolving. In particular, the responsible use of artificial intelligence, data protection requirements and the regulation of medical products require careful preparation from companies before market entrance with new products.
Triconsult sees the CHN ecosystem as an opportunity to strengthen the capacity of Finnish health sector companies to grow and internationalise. The company’s expertise complements the ecosystem’s capabilities, especially when innovative digital health solutions are progressing towards certification and new international markets.
