Med-Tech Innovation June 18, 2021
Richard Poate, senior manager at TÜV SÜD, a global product testing and certification organisation, discusses how health apps can be regulated, and offers best practice advice to manufacturers.
As well as medical device apps becoming a growth area in healthcare management in hospital and community settings, the role of apps used as part of fitness regimes and for social care situations is also expanding.
IEC 82304-1:2016 – Health software – Part 1: General requirements for product safety – applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware. To be used by manufacturers, it covers the entire lifecycle including...