This company was considering a mobile app for tracking a set of observed symptoms on a baby with timestamps and keywords. The main purpose was to ease the reporting of observed baby behavior’s by the mother to the practitioner. Even if most of the features would not trigger the classification as a medical device under 93/42 MDD or 2017/745 MDR, one feature attracted our attention: the ability of the mobile app to self-detect some patterns and to recommend an immediate transfer to the hospital. This single aspect made the difference and triggered the need for regulatory compliance as a medical device.

In this situation, Medidee proposed following services:

  • Stabilization of the intended use in relationship with the demarcation line with medical devices
  • Confirmation of the classification as a medical device, for EU (new MDR changes classification) and US
  • Training of the software engineering team on 62304 & HIPAA
  • Classification of the software risk class as per 62304
  • Documentation of the compliance plan
  • Review of the validation protocols
  • Integration 62366 usability testing
  • Coaching during the establishment of the Technical Documentation

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