Medical technology is a key component of health care. State-of-the-art technologies and processes make an important contribution to the prevention, diagnosis, and therapy of illnesses and diseases for health systems throughout the world.
The driving trends in medical technology, such as digitalization, automation, and an increased awareness of sustainability, are being confronted with ever-tightening regulatory requirements and legal changes. This means that, for manufacturers, the requirements regarding quality, safety, and effectiveness are continuing to increase, while at the same time there is high time and cost pressure. Increasing approval costs and extraordinary situations are further exacerbating the technological and economic challenges in the industry.
As a development service provider, Bertrandt has many years of experience in medical technology and is, of course, certified according to ISO 13485. Whether you need product development, design, simulation, hardware and software development, testing, validation, data collection and AI-supported evaluation, quality management through to production: our highly qualified specialists create and process targeted solutions for you that are tailored to your requirements – not only for large companies, but also for small and medium-sized enterprises and start-ups.
In addition to extensive certification, we also have in-depth experience with national and international regulatory and legal requirements, thus enabling us to ensure, right from the start, that your project meets all the necessary requirements and to guarantee you the highest level of legal certainty with maximum cost-effectiveness.
