We support manufacturers and operators of medical devices in attaining their goal of bringing to market and implementing products of maximum safety. Together with our subsidiary, Acentiss GmbH, we ensure the functional safety and usability of products as well as the implementation of modern workflows:
- Process consulting
- Safety engineering (according to ISO 62304, IEC 60601-1)
(Requirements management, verification and validation)
- Risk management processes in compliance with ISO 14971 and ISO 62304 (FMEA, FTA)
- Quality management (according to ISO 13485)
- Human factors engineering in compliance with IEC 62366
(Human-machine interface, workplace analysis, design thinking, creation of prototypes/mock-ups, eye tracking analysis)
(Methods of user-centred design like design thinking and safety analysis like FMEA)
Here you can find our services for Medical Technology Sector
Our references - two sample customer projects
1. Verification and validation (V&V) of medical devices
We assisted one of our customers on site during the critical project phase of verification and validation (V&V) of a medical device. For this we drafted test plans, ran function testing and coordinated external testing in compliance with IEC 60601-1, IEC 60601-2-18 and IEC 60825-1
After the testing phase we created the traceability matrix and finally reviewed the verification report. Thus, we played a vital role in the preparation and the successful completion of a gate deadline.
It was in particular the very close cooperation, high flexibility and solution-oriented methods of our experts that convinced our customers. Of special added value was the combination of profound know-how in project management, development in compliance with V-model and regulations of medical technology – all from a single source.
2. Approval of a medical device
For a medical device to be approved many experts have to work as closely together as possible. Joining in this "marathon" are many disciplines such as project management, risk management, quality management, product management, system engineering, usability engineering and regulatory affairs.
We have covered important stages of this marathon on site together with our client. The diverse activities involved in the approval process were harmonised, coordinated and executed in close collaboration with the project manager. We ensured the required quality of the design history filethrough formal reviews. The coordination encompassed the entire time management: we made sure that all the deadlines were met and that the medical device acquired approval in the scheduled timeframe.