Health – We harness human insight and intelligent technologies to impact many lives.
All we do aims for impact that lasts. In healthcare, gaining the maximum impact means that the end result will be a regulated “software as a medical device”. That’s why we have developed a scaleable service model which we call Solita RegProof™.
We work on every step of people’s lives for health and well-being. We create services with human insight and intelligent technology: helping individuals, health care professionals and the whole society to live better life.
How can we help
Delivering safe, secure and impactful regulated digital solutions for health and wellbeing
If you are looking for an experienced partner to help you take care of the whole lifecycle of a medical device, take a seat!
We know what it takes to develop medical devices in an agile and effective way. We have a certified ISO 13485 quality management system for providing outsourced services covering the whole lifespan of a medical device, have helped a number of customers in their own journey, have a medical device of our own, and also very active in the research field.
All this is packaged to our Solita RegProof™ service model.
Together to success with shared goals
Creating a medical device takes time. If you have an idea for one of such today, you should safely budget 1,5-2 years until it’s on the market (since one year goes typically to the certification process).
We are ready for long-term partnerships, and believe that real success requires sitting on the same side of the table. Having shared goals, feeling like our team and your team are on the same company, not just being a customer and a supplier.
An example of multi-year partnership is the development of OmaOlo, the Finnish national symptoms assessment service.
From vision to production and beyond
We are prepared to be your strategic partner to bring the fragile ideas to reality, taking care of your service throughout the lifecycle, all the way from vision to production and beyond to the post-market surveillance phase. You’ll bring the clinical knowhow and responsibility of being a manufacturer, we’ll bring the rest.
One of our customers made a strategic decision of not having any software development capabilities inhouse. Instead, they outsourced the whole ISO 13485 design, development and maintenance processes to Solita. We are designing their medical software, we will develop it, and eventually we will take care of it while it’s on the market.
Stress-free and fast release cycles
When you make a medical device, the most important thing is to make sure that it is regulatory compliant. Compliancy will ensure that the end result is safe and ready to the market. No wonder why it is typically the the biggest headache for anyone responsible of manufacturing such devices.
We have invested a lot of time and efforts to make our RegProof™ service model and processes very good and agile with fine-tuned workflows, high-level of automation in document and evince generation, so that we can have fast release cycles without stress. The goal is that after each and every development sprint you would be able to create a new release with minimum extra overhead regulatory work.
This improved efficiency has been also validated in real life. One of our customers asked us to help them, as with their existing process it took 6 months to get a new release published after the actual software was ready. We stepped in and guided them to make the process more agile and efficient: nowadays they can have new release every month.
Experienced industry thought leaders at your service
When you select Solita as your partner, you know that you will get a safe, secure and impactful end result. We will guide you through the process, and can help even with the trickiest questions.
We have and continue to invest a lot in the research topics of how to design medical devices, how to create them in agile way, how to combine machine learning with medical devices and so on. And that all is available to you once we will start working together.
Our services for Wellbeing counties
Welfare reform challenges for change
The reform of the Wellbeing Region is a holistic transformation of health and wellbeing services, but at the same time, care professionals continue to carry out their important work on a daily basis. Success in meeting the objectives of the reform will require careful choices and determined development work. We support health and wellbeing service providers and the fire and rescue service in this reform. We help to address development challenges in a value-driven way, putting the needs of patients, professionals and organisations first. Changes in operating practices, continuous care pathways across systems, leveraging the data assets of wellbeing regions and secure technology solutions require industry expertise, including from partners.
See more our work
Kela – The Social Insurance Institution of Finland Significant opportunities for Kela through AIOur goal is for AI to improve daily lives in Finland as much as possible. This is an incredibly strategic partnership, which will have a significant effect on peoples’ lives.
Valkeakoski Health Center Hospital Smoother daily operations, increasingly satisfied nurses – Pulse speeds up activities at the Valkeakoski hospitalPulse helps plan and lead daily operations of Valkeakoski hospital wards, resulting in higher quality and more satisfied staff.
Istekki Three wellbeing services counties implemented a common data pool solution – for the benefit of the taxpayerIstekki, Solita and Productivity Leap implemented a Social and Health Services Data Pool solution, which can be replicated in other wellbeing counties, saving ten times as much time, money and work.
Fimea Updating Finnish pharmaceutical dataTogether with Fimea, we modernised the register of medicinal products and marketing authorisations. As a result, Fimea now has an up-to-date and easy-to-use register with correct information on all medicines in Finland.
Coxa Pulse gets modern care work running smoothlyDeveloped by Solita in cooperation with the Coxa Hospital for Joint Replacement, Pulse is a real-time enterprise resource planning (ERP) system for inpatient wards that overcomes many day-to-day challenges.
DigiFinland Omaolo assesses user health and directs them to the correct servicesThe Omaolo service makes it possible to track personal well-being and access symptom and service assessments online, collecting care and service plan data in one location.
THL Koronavilkku – the world’s most downloaded coronavirus appSolita created Koronavilkku – the world’s most downloaded coronavirus app that was designed to break coronavirus infection chains,
Nyanssi Terapiapalvelut Pocket Therapist supports therapy independent of place and timeThe Pocket Therapist app supports the therapeutic relationship and the psychotherapeutic work associated with autonomic nervous system arousal and emotion regulation also outside actual therapy sessions.
Palveluohjain Palveluohjain for improved everyday life and servicesSolita participated in the development of Service Coordinator, a solution enabling the use of digital services regardless of time and place.
Can regulation make design more interesting?
Read how regulation can make the design of a medical device, for example, particularly interesting.
Solita Health receives ISO 13485 certification
Solita Health has received ISO 13485 certification for smart medical device development
Solita health care sector grows in Sweden
Solita wins major framework agreement with Inera/Healthcare guide 1177
Solita joins Secure e-Health R&D project
Health data save lives – Solita joins international Secure e-Health R&D project
Blog post on RegOps
Diving into the dilemma of agile software development in regulated industry.
Foundations of medical device software cybersecurity compliance
Learn the foundations for effective cybersecurity risk management in the medical device software context.
Want to know more? Contact us!
Risto Kaikkonen Director, Solita Health
[email protected] +358 415 368 745
Vesa Sainio Director of Operations, Solita Health
[email protected] +358 40 506 2268
Kimmo Kivirauma Business Director, Solita Health
[email protected] +358 40 7390 239
Sanna Virkkunen Business Director, Solita Health
[email protected] +358 40 3539 901
Antti Brunni Business Director, Solita Health
[email protected] +358 44 55 44 669