Trifork Digital Health operates in the healthcare domain and provides both regulated and non-regulated software. To ensure compliance with the European Union Medical Device Regulation (MDR) in the regulated software domain, Trifork has obtained the ISO 13485 certification.
ISO 13485 is an international standard that sets guidelines for quality assurance in the production of medical devices, including Software as a Medical Device (SaMD). Adhering to this standard for quality assurance ensures that patients can rely on our software and expect it to be safe and effective.
Obtaining the widely recognized ISO 13485 certification is an important milestone for Trifork as we expect it to significantly enhance our competitiveness internationally by being able to demonstrate compliance with regulatory requirements (such as those set by the FDA and MDR) which increases the chances of getting our software approved and marketed globally.
At Trifork, we recognize the increasing pressure on the European market regarding certifications under MDR and we have taken proactive steps to lead the way in this area. Our unique approach sets us apart as first movers within nationwide digital healthcare infrastructure solutions. By incorporating this new expertise into Trifork, we can enhance our products and projects, making them even more valuable to our customers.
The demand for CE certified solutions will increase in the future as more customers will be subject to the MDR. With ISO 13485 certification issued by BSI, we can demonstrate that our software is safe for patients and meets the highest level of security standards. This not only instills confidence in our customers but also satisfies the National Health Agencies. This new Trifork capability is scalable and can be extended to all Healthcare Business Units across Trifork. With this, we can secure our own solutions, existing customers’ solutions, and future customers’ solutions.
At Trifork Digital Health, the certification process for ISO 13485 is managed by our Software as a Medical Device (SaMD) Business Unit. This unit documents the procedures for designing, developing, testing, manufacturing, installing, maintaining, and servicing the software. This allows for flexibility in the technology used during development, enabling Trifork to stay at the forefront of technology and advancements.
As there are increased requirements for ensuring the safety of our products, we are accountable to each of the applicable national health agencies in the European Union. Currently the Danish Medicines Agency, since we have our first medical software solution placed in the Danish market. We prioritize transparency by documenting all actions and decisions, allowing for easy traceability. A risk-based approach is taken in all our development to ensure the safety of patients and the clinical benefit provided by our software. The development process is managed through established frameworks, with close collaboration between the development team, a risk team, and a clinical team. This approach is unique and sets us apart in the industry.
Obtaining the ISO 13485 certification means that an external party has verified and approved our technical documentation. It is the most comprehensive certification available and allows Trifork to produce software that is even more user centric. This certification also signifies an increased level of responsibility on our part.
ISO 13485 is an essential standard for ensuring the quality and safety of medical devices. It not only enhances trust from customers and regulatory authorities, but it also provides a competitive edge in the international market.
With this certification, Trifork is now able to serve a wide range of clients both nationally and internationally, completing the full circle of our service offering.
SaMD & MDR Expert · Digital health
CCO & VP, Trifork Digital Health
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