mobile app regulations

The FDA and European regulators encourage the development of mobile medical apps to enable patients to manage their own health and wellbeing, yet the regulatory status of a smartphone remains a source of confusion. Novarum DX, has produced a whitepaper which provides guidance on the regulation of mobile medical apps.

Download our whitepaper and listen to what our regulatory experts have to say on:
– The regulatory requirements in the USA and EU
– What constitutes a Mobile Medical Application
– When medical apps require regulatory clearance, e.g. 510(k)
– The status of mobile phones within the system
– How to control app development to meet regulatory requirements
– How regulators view Operating System upgrades
– How to maintain validation of medical apps

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