UID Medical & Pharma: Optimum design, validation and documentation in line with standards

User errors on medical devices are one of the most common causes of accidents in the healthcare sector. The consequences are often serious, as it is frequently a human life that is at stake if the manufacturer fails to integrate good usability and effective risk management into his development process. Safe and intuitive products can reduce these errors. We accompany you from the conception of the product idea to the development and the testing of the user interface through to the submission of the Usability Engineering and Risk Management files to the certifying body.

We validate medical products in usability tests with representative users.
We advise and support you in designing medical appliances and medical-technical applications in the following fields:
diagnostics/point of care testing
therapy (e.g. in ophthalmology/surgery/pain therapy/diabetology)
support of vital functions (life support machines/lung ventilators)
data management in studies on the effectiveness of drugs
medical and pharmaceutical information systems
Our experts analyze, design, validate and program user interfaces for
measuring equipment
diagnostic software
life support systems
medicinal laser systems
laboratory and hospital information management systems
software systems for pharmaceutical materials management
websites for medical technology companies
Usability validation

The German industry standard DIN EN 62366 requires a usability validation process to check the suitability for purpose of a medical product. We validate medical products in usability tests with representative users. To complete the validation process successfully, we check your Usability Engineering File in advance. This is the only way that the validation contents and the required acceptance criteria can be accurately defined. Based on the test results and in close cooperation with the risk management department, we identify and evaluate application and residual risks of the product.

Usability can save lives

The operational safety of equipment in the medical field is of vital importance in two ways: Firstly, medical devices save patients' lives. Secondly, easy-to-understand and safe operation can avoid errors that could have serious implications for the patients. The essential requirements for successful design are sound knowledge of usability and medical interdependencies as well as the integrative use of this knowledge.

Whether in a medical practice, in the operating room or in a clinical study: We develop operating concepts and user interfaces that take into account the wide variety of operating situations. We design innovative technologies that meet the many different needs and knowledge levels of specialist medical staff. From senior physicians to nurses, from patients to family carers: Every user can quickly grasp and apply this new type of technology.