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". It is intended for use as a general technical guide in conjunction with relevant trusted standards and good practices.

This standard covers computer software applications for mobile devices, smartphones and tablets, installed / downloaded with a medical device / medical intended purposes, including lifestyle, desktop, online, native or web apps designed for use by the general public, patients, carers, healthcare professionals to help manage a specific medical condition and communicate with clinicians, and other healthcare providers.

This standard specifies requirements for intended performance, design, design evaluation, manufacture and information supplied by the manufacturer, and tests to demonstrate compliance with applicable regulations.

“Although the meaning of a medical device is well-defined and recognised, the meaning of a medical device app is not”, says Haroon Atchia, CEO and Technical Director of QFI. “The current lack of technical criteria on medical device apps currently manifests in haphazard app design, utility and relevance when assigned medical or allied use. This standard identifies/defines requirements to ensure a medical device app is suitably characterised, designed and fulfils specified requirements. .”

The standard is available from QFI upon request, please contact [email protected]. Price: 120.00 GBP.

About Quality First International (QFI)
QFI is a London-based medical device consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.

For further information please contact:
Tel: +44 (0)208 221 2361, Email: [email protected], Website: https://qualityfirstint.com.