Medical device standard QFIS 002:2022 on Medical Apps published by Quality First International

This sector-specific standard has been designed to help manufacturers, developers and technical assessors design, develop and evaluate medical device apps

London-based medical device regulatory consultancy Quality First International has published Medical Device Standard QFIS 002:2022 Medical device apps - Technical specification - design, development and evaluation . This standard is intended for use as a general technical guide for medical device apps with the aim of ensuring applicable requirements are met by the medical app technology with respect to medical device function, safety and performance.

This standard is suitable for apps designed to be used by professions allied to medicine (e.g. biomedical engineering, chiropody, dietetics, medical physics, occupational therapy, orthoptics, orthotics, physiotherapy, prosthetics, psychology, radiography and speech therapy), in various practices (e.g. electroencephalography, electrocardiography, hearing aids and hearables, audiometry, surgical appliances, ultrasonics, nuclear medicine, industrial therapy and dental ancillary support) and, as necessary, by lay persons.

“This sector-specific standard on medical device apps was motivated by recognition of a void in published coherent technical criteria for medical device apps, presently manifesting in haphazard app design, utility and relevance when assigned a medical or allied use”, says Haroon Atchia, CEO and Technical Director of QFI. “This standard therefore specifies requirements for intended performance, design, design evaluation, manufacture and information supplied by the manufacturer, and tests to demonstrate compliance with applicable regulations.”