Bertrandt offers customized solutions from concept to production of medical technology products in accordance with ISO 13485. Product development, simulation, testing, HW/SW development.
Medical technology is an essential part of healthcare. State-of-the-art technologies and procedures make an important contribution to healthcare systems worldwide in the prevention, diagnosis and treatment of diseases.
Driving trends in medical technology, such as digitalization, automation and an increased awareness of sustainability, are coming up against ever stricter regulatory requirements and legal changes. For manufacturers, the demands on quality, safety and efficacy continue to rise, while time and cost pressures remain high. Increasing approval requirements and exceptional situations are further exacerbating 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, ISO 13485 certified. Whether product development, design, simulation, HW and SW development, testing, validation, data collection and AI-supported evaluation, quality management through to production:
Our highly qualified specialists create and work on targeted solutions tailored to your requirements – for large companies as well as for small companies, SMEs or start-ups.
In addition to extensive certifications, we have in-depth experience of national and international regulatory legal requirements and ensure that your project meets all the necessary requirements right from the start, guaranteeing you maximum legal certainty with maximum cost-effectiveness.
With over 50 years of experience as a development partner, you benefit from a unique service profile when working with Bertrandt:
In a networked group structure, around 14,000 employees* in the medical technology, aviation, automotive and industrial sectors ensure a cross-divisional transfer of knowledge. At the same time, Bertrandt is also an economically stable company behind the medical technology sector that is ideally equipped for current and future investments.
