Safety Medical Technology Sector

Our aim: safe medical products and modern workflows in health care

The "medical technology of the future" has already arrived in health care: digitised processes, robotics and the use of AR/VR are state of the art in the manufacture of modern, ever more sophisticated medical products. A comprehensive set of rules has been established to ensure the general demands of medical technology and health care as well as patient safety.

The new Medical Device Regulation (MDR) and the FDA Guidelines for Usability and Cyber Security include a new, comprehensive catalogue of requirements. A complex set of rules has been drawn up.

Usability (IEC 62366) and risk management (ISO 14971, ISO 62304) must be considered together – and this right in the product development phase.

Our services

We support manufacturers and operators of medical products 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
    Requirements management, assistance in verification and validation
  • Support of risk management processes in compliance with ISO 14971 and ISO 62304 (FMEA, FTA)
  • Human factors engineering in compliance with IEC 62366
    Human-machine interface, job analysis, design thinking, creation of prototypes/mock-ups, eye tracking analysis
  • Training/coaching
    Methods of user-centred design like design thinking and FMEA

Here you can find our services for Medical Technology Sector

 

Our references - two sample customer projects

1. Verification and validation (V&V) of a medical product

We assisted one of our customers on site during the critical project phase of verification and validation (V&V) of a medical product. 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. In this way we were instrumental in the preparation and successful achievement 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, V-model development and rules governing medical technology – all from a single source.

2. Approval of a medical product

For a medical product to be approved it is necessary for many experts 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 the customer. The multitude of activities involved in the approval process were harmonised, coordinated and executed in close collaboration with the project leader. We ensured the required quality of the product file through formal reviews. The coordination encompassed the entire time management: we made sure that all the deadlines were met and that the product acquired approval in the scheduled period.