Navigating the EU regulations for medical device software can be confusing. The rules are complex. The details are daunting. But with the right guidance, it doesn’t have to be overwhelming. Understanding key areas can simplify the process, allowing your solutions to reach the market faster and make a significant impact.
At Trifork Digital Health, we possess both the expertise and certifications necessary to guide you through this complexity. Since February 2023, we have held the ISO 13485 certification, ensuring our software meets the highest standards of safety and quality. This certification allows us to design and develop software that complies with strict medical device regulations, supporting our commitment to delivering safe and reliable digital health solutions.
Our certification enables us to assist with CE-marking applications and provide the tools necessary for compliance with the Medical Device Regulations (MDR). This includes the implementation of an electronic Quality Management System (QMS), ensuring continuous compliance and quality assurance.
Whether you are navigating the complexity of a CE marking, preparing for the AI Act, or just seeking guidance for the international standards ISO 13485, ISO 14971, IEC 62304 and IEC 62366, we are here to support you every step of the way.
When developing a digital healthcare solution for the EU market, it is essential to understand whether it classifies as a medical device and hereby requires a CE mark. The CE mark demonstrates that your product complies with the Medical Device Regulation (MDR 2017/745), and that it meets the requirements to safety and performance. The CE-mark allows your product to be legally marketed and sold within the EU.
All medical devices require a CE-mark. It is important to note, however, that the route to regulatory compliance is dependent on a risk classification. Low-risk devices may not require approval with the involvement of a notified body, while higher-risk devices do.
Here’s what you need to do to bring your medical device software to market:
At Trifork Digital Health, we support companies working with Medical Device Software by navigating regulatory requirements and bringing digital health products safely to market. We offer guidance and support throughout the entire CE-marking process, including implementation of an electronic Quality Management System. We are also here to guide you if your product is subject to Regulation (EU) 2017/745 article 5.5, exempting products from assessment by a Notified Body. Even if your product is exempted from assessment, you as a manufacturer still must comply with applicable rules and regulations.
Our dedicated team has extensive in-depth knowledge of medical device software, and the regulatory frameworks that surround it. This includes MDR, the AI Act, and relevant standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 62366. As an ISO 13485-certified organization, we understand what it takes to develop regulated digital health solutions with safety and quality in focus.
We aim to build software that not only meets regulatory demands but also creates value in real-world healthcare. Whether you need support throughout the full process, from compliance strategy to technical implementation, or only in specific areas, we can step in where it makes the most sense for you.
In addition to advisory and development services, we offer the option to structure- and create the necessary documentation, for either your quality management system, technical documentation, or both. This can provide you with a smooth path from idea to market readiness.
Our regulatory advisory services are offered in three levels, aligned with Trifork’s Inspire – Build – Run model. Whether you need early strategic input, support in documentation, or ongoing maintenance of compliance, we provide tailored advisory packages that meet you where you are in your journey.
Vice President Trifork Digital Health
Senior Digital Health Advisor & Nurse
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