MEDICAL SAFETY DESIGN

Whether systems for life support, monitoring, diagnosis or therapy, used by doctors, medical staff or patients themselves – we design innovative medical products that are safe and intuitive to use, and support you in their regulatory approval.

Our proven approach combines Human-Centered Design according to ISO 9241 with usability engineering for medical devices according to IEC 62366-1, while considering risk management under ISO 14971 and EU MDR requirements. This brings safety, usability and user needs into product development from an early stage.

With user-centric products and services, you can not only differentiate yourself from your competitors, but also set new standards within your product category. This strengthens customer loyalty and your brand. In this way, user-friendly product development contributes to your long-term economic success.

As a partner company of YOOme, we also cover the entire lifecycle of medical products. As a manufacturer, you can access all the services of the entire medical device journey via YOOme: Ideation, conception and requirements engineering, medical hardware and software development, cybersecurity, validation and verification, design, usability & UX, market placement and maintenance.