Requirements and fields of application for software medical devices

Target group

  • Start-ups
  • Medical software and DIGA developers

Your requirements

You are involved in a project or are planning a project for which routine data from health insurance funds are to be used for research purposes or for an AI application.

Our offer

We offer initial advice on the topic of medical devices / DIGA, for example to clarify whether a planned application is a medical device. Another aim is to create awareness of regulatory requirements that could be associated with the medical device to be developed, so that these requirements can be taken into account at an early stage in product development. Furthermore, sources of information are presented that could be used to clarify detailed questions and implement further training, if this is necessary.

Requirements

None

Success stories

Within our consultancy, we provide awareness of regulatory requirements that may be associated with the medical software product or DIGA being developed, so that these requirements can be taken into account at an early stage of product development.

Service type

Consulting

Contact person

Bart de Noord

Planned start date

from now on