This sector-specific standard helps manufacturers understand and ensure sustainable environmental realisation by considering recognised system boundaries, total medical device life-cycle, and environmental risk-thinking through a dedicated, stochastic management system.
London, 10 August 2022
London-based medical device regulatory consultancy Quality First International has published medical device standard QFIS 003:2022 Medical device environmental (waste) management system specification. It is intended for use as a sector-specific management system and to be used in conjunction with relevant trusted standards and good practices.
The standard is applicable to all types of medical devices, support services, externally-provided raw materials, intermediate products and components, constituents, processes and utilities applied to produce, supply, sustain and ultimately dispose of medical devices.
“Sustainability may not be achieved without both full characterisation of a medical device to its environmental fundamentals and its imprint throughout its complete life-cycle, says Haroon Atchia, CEO and Technical Director of QFI. This is crucial in all environmental compartments relevant to a medical device, defining its planetary or system boundaries and safe operating space, intertwined with its basic environmental performance and impact.
Standard QFIS 003:2022 is the first and only standard on this specific subject matter to date. Atchia further explains that “only QFI can assist medical device manufacturers with the know-how and practical resources to implement concepts and radical solutions described by our standard. Also, only QFI’s environmental technical specialist team can conduct comprehensive assessments to the standard. We offer these services as part of our business programme to our members but can also do so on an individual project basis.”
The standard is available from QFI upon request, please contact [email protected]. Price: 175.00 GBP. The price for QFI Medical Device Environmental Management Programme members is 139.00 GBP.