The sector-specific standard was developed to help manufacturers improve the function of medical devices and medical device systems with respect to safety and in accordance with well-established international norms.
London-based medical device regulatory consultancy Quality First International has published Medical Device Standard QFIS 001:2021 Medical devices – Functional safety – Product development at system level to help manufacturers achieve safer functionality of medical devices and medical device systems.
This standard is suitable for all device types and classifications with the pursuant aim of ensuring a high level of safety and protection in accordance with Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC, Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) and the UK Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, SI No. 1478, as relevant. It is intended for use as a general guide in conjunction with relevant trusted standards and good practices.
“Safety is a fundamental qualitative and quantitative element in medical device development; however, this remains intangible for the industry in the absence of precise legislation or official standards defining functional safety requirements”, says Haroon Atchia, CEO and co-founder of QFI. “The activities described and recommended in the standard are intended to achieve improved safety of medical devices and are consistent with well-established international norms, so they should not present any additional burden to an organisation.”
The standard is available from QFI upon request, please contact [email protected]. Price: 69.00 GBP.