Through the system verification and validation phase, we have supported one of the largest medical device manufacturers in the field of ophthalmology and neurosurgery in the development of a confocal laser endomicroscope.
The tasks of our experts consisted of preparation of the verification plan, support for internal tests, and coordination of external tests required according to IEC 60601-1 & IEC 60601-1-2. The maintenance of the requirements and verification was carried out using suitable requirements management tools.
At the same time, we ensured the awareness and the empowerment of the internal project team members through the use of Best- Practices regarding to V-model-compliant development and work package maintenance, as well as the use of “Coaching-on-the-Job“.
As a result, a consolidated technical file is delivered to the customer and the project goal is measured through the certification of the device in the different markets.