Safety Medical Technology Sector

Our aim: safe medical devices 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 devices. A comprehensive set of rules has been established to ensure patient safety which is the central requirement of medical technology and health care. Usability (IEC 62366) and risk management (ISO 14971, ISO 62304) must be considered together – as early as in product development.

The new Medical Device Regulation (MDR) and the FDA Guidelines for Usability and Cyber Security include a new, extensive catalogue of requirements which has led to the creation of a complex set of rules.

“Quality Management of Software in Medical Technology” is especially important in Germany. VDI 5702 Page 1 “Medical Device Software – Medical SPICE Process Assessment Model” describes a process assessment model which fulfills the ISO/ISEC 15504-2 requirements. It specifies a framework for process assessment and the minimum requirements for the execution of such assessments to guarantee consistency and repeatability

Our services

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
    (Requirements management, verification and validation)
  • Risk management processes in compliance with ISO 14971 and ISO 62304 (FMEA, FTA)
  • Human factors engineering in compliance with IEC 62366
    (Human-machine interface, workplace analysis, design thinking, creation of prototypes/mock-ups, eye tracking analysis)
  • Training/coaching
    (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, V-model development 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.