Documentation

Documentation plays a not insignificant role in the development of medical technology. In addition to the documents required for production, this also includes the documentation of market observation, clinical evaluation, risk management and other aspects..

The documentation requirements will become even more stringent as a result of the new directive, as this comparison shows.

My offer

• Revision of the existing drawings
• Creation of missing drawings
• Creation of development documentation (user needs, development plan, ...)
• Documentation of the validation and verification of the development
• Creating the risk management file