Sustainable medical device development
The healthcare market is under immense pressure to be efficient and innovative. In addition, ever stricter legal requirements apply. One possible answer is the digitalisation and networking of medical devices with their existing medical environment. This applies to the exchange of data for treatment, care and diagnosis as well as with the administration.
Medical devices with a high software content are already the order of the day. A clearly defined product vision, clean implementation and documentation of the development in accordance with the approval are indispensable prerequisites to survive in the highly regulated medical environment.
In medical technology, PTA essentially addresses four areas:
- We support you in the development of product ideas and help you implement them.
- We make your medical devices fit for the digital era and ensure that they comply with legal requirements regarding software and documentation, and are ourselves ISO 13485 certified.
- We integrate your medical devices into existing healthcare ecosystems, also thanks to our experience from more than 400 interface projects.
- We support and develop software within the framework of ISO 62304 over the entire life cycle, including maintenance.