Causalus software is now CE certified


Causalus software is now CE certified

Helsinki-based health tech company Causalus Oy has announced medical device CE marking for their first product. Namesake of the company itself, Causalus is the world's first dedicated software for monitoring medication effectiveness and conducting medication reviews. Causalus' improved medication follow-up and review process takes 10x less time, enables continuous medication change impact tracking and digitally documents every action for complete transparency. This means safer medication and less drug adverse reactions for the patients, and massive resource savings for healthcare professionals, organisations and municipalities alike. 

Panu Engelvuori, the COO and Quality Manager of Causalus says: “Since we manifest safer medication for everyone, it was quite clear that product quality will be one of the most important cornerstones we establish our company upon. The CE marking indicates that we are committed to adhering with the highest standards of quality when it comes to the development process of our software, managing patient risks and tracking performance of our solutions.”

Close collaboration with regulation experts

Causalus Oy has worked in close collaboration with Finland’s top experts from Lean Entries Ltd to build a Quality Management System based on the international medical device standards, such as ISO 13485 for quality management system, ISO 14971 for risk management, IEC 62304 for software life cycle management and EN IEC 62366 for medical device usability. Adhering to these globally recognized standards also paves Causalus’ path to the world wide markets. 

“This is a major milestone on the regulative pathway for Causalus Oy. I want to thank the magnificent Causalus team and also Lean Entries experts Heikki Pitkänen, Ilona Santavaara and Leena Raunio for getting the quality management processes up and running in record time, especially knowing that regulatory compliance projects can be paralyzing tasks even for big corporations.” says Dr. Sirkku Karinen, the CTO of Causalus Oy. 

Ilona Santavaara, regulatory affairs and quality assurance expert from Lean Entries chimed in: “It has been rewarding to work together with the Causalus team because they are highly motivated and the idea behind their product is great.”

Ready to enter the global market

Panu Engelvuori concludes: “We have a unique solution to the polypharmacy problem costing hundreds of billions of euros each year in healthcare expenditures and causing unnecessary suffering to patients. Now we are super excited to be able to introduce Causalus to markets in the Nordics and Europe, and soon in North America as well. If you have a friend or relative who takes five or more prescription medicines a day, you should definitely take a closer look at how we can help!”

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