All medical devices (including apps, of course) are subject to legal and industry-specific regulations. From conducting a risk assessment in accordance with recognized standards to preparing the technical documentation and issuing a valid declaration of conformity – many hurdles must be overcome on the path to approval as a medical device.
In this tutorial, Christoph Sing from MVI PROMIND gives you practical tips and insights into the following questions:
- What do I generally need to consider regarding the legal framework?
- What are these standards for?
- How do I specifically organize the implementation of corresponding requirements?
- What costs should I expect?
- How much time do I have to invest?
- What scope for action do I have?
