How are mobile medical apps regulated?

Event Detail

Understanding the regulation of mobile apps with a medical purpose is essential, as the future of healthcare shifts towards decentralised point of care testing (POCT).

View our webinar recording and listen to Dr Alasdair Christie, Head of Regulated Product at Novarum™ Dx, as he discusses the regulatory frameworks and process controls required to develop a mobile medical app.

Key Learnings:

  • What constitutes a mobile medical app?
  • Developing apps in a regulated environment
  • Deliverables for EU & US requirements
  • App development lifecycle & controls
  • How to maintain validation of medical apps
  • FDA alignment to global QMS standards

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