Novarum Mobile Reader Solutions

We develop next generation technologies for point of care diagnostics

Download Whitepaper

The regulatory status of the mobile phone as a medical device can often be a source of confusion. Download our whitepaper which sets out clear regulatory guidelines for mobile medical apps:


Mobile Medical App Whitepaper

The FDA and European regulators encourage the development of mobile medical apps to enable patients to manage their own health and well-being, yet the regulatory status of a smartphone remains a source of confusion.

  • The regulatory requirements in the USA and EU
  • How regulators view Operating System upgrades
  • How to maintain validation of medical apps

We have produced a whitepaper available for download which provides guidance on the regulation of mobile medical apps.

Contact us to learn more about the regulation centred around apps with a medical function and how Novarum can support your mHealth strategy.

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