From mobile apps to digital biomarkers, transformative technologies – such as artificial intelligence, machine learning and virtual reality – are enabling the creation of unique and novel digital health innovations, ultimately changing our definition of what a medical device is. By crossing the line from tracking, to diagnosis and treatment using tools like AI symptom checkers, a product is no longer classified as a wellness consumer product, but instead, it becomes a medical device. Spanning from sample detection and diagnosis to the treatment of mental health disorders, the opportunities are endless in this expanding industry.
Medical and governmental bodies are having to adapt to these ever-evolving developments, with Germany now prescribing mobile apps to diagnose and treat medical diseases. However, with no restrictions on where these devices can be developed, start-ups are emerging across Europe to disrupt this growing sector, with a specific focus on the German market.
The medical device industry is a highly regulated area, requiring CE accreditation to confirm customer safety in order to ensure a device offers the correct treatment for the intended patient. Spanning the whole product development process, rigorous testing and documentation is required to meet the CE certification criteria, often including external audits by notified bodies, before it can become a viable commercial product on the market.
LINK Medical is a Northern European contract research organization offering full and flexible services to support companies globally and across Europe, from concept to CE certification and commercialization. With in-house professionals providing extensive start-up focused experience, we understand the budget and expertise support needed when developing a concept into a medical device. Our team offers specialized medical device expertise and has successfully facilitated the development of AI systems that analyze medical images or detect and diagnose blood samples. We are continuously investing in and expanding our team, adding expert insights to our seamless network of intellectual capital across Northern Europe. From formulating an intended use statement and attracting key funding, to implementing quality systems and executing clinical trials, LINK Medical is your one source for medical device solutions in the digital health revolution.
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