Medical Apps or Wearables may be medical devices – Nearly all depends on the intended use!
Medical App and Wearables as well are borderliners and rough terrain for the regulated product classifications according to MDD, MHRS, FDA and many other competent authorities. The Classification is not allwasy as easy as it might look and small adjustments on the intended use can make great changes.
If your devices is a medical device or medical app, you have to go all the way of the device registration and approval – This path we can share with you.
- Definition of the intended use and classification of the product
- Appointing of the regulatory strategy
- Support during development and creation of the DHF
- Regulatory Affairs during the product life cycle
- Registration and support during the approval of the medical device
- Quality management during production and sales