LATEST NEWS

10 August 2022

New medical device standard QFIS 003:2022 on an environmental (waste) management system specification just published by Quality First International

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 … Continue reading “New medical device standard QFIS 003:2022 on an environmental (waste) management system specification just published by Quality First International”

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22 June 2021

New article on the design principles of electrical surgical instruments

Quality First International has published an article that examines the difficulties in analysing antecedent medical device technology used in modern medicine against new or evolving regulations. London-based medical device regulatory consultancy Quality First International (QFI) … Continue reading “New article on the design principles of electrical surgical instruments”

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9 June 2021

New Guidance: Understand how to apply general personal data protection to medical devices to avoid non-compliance and fines

Quality First International has published a guidance book to raise awareness and preparedness of medical device manufacturers with regard to Regulation (EU) 2016/679, encompassing additional elements of the UK Data Protection Act 2018. This sector-specific … Continue reading “New Guidance: Understand how to apply general personal data protection to medical devices to avoid non-compliance and fines”

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4 May 2021

New medical device standard QFIS 001:2021 on safety-related functions and activities just published by Quality First International

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 … Continue reading “New medical device standard QFIS 001:2021 on safety-related functions and activities just published by Quality First International”

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1 March 2021

Leadership through eco-friendly medical device manufacturing and waste management: new regulatory service available from QFI

The London-based medical device regulatory consultancy Quality First International (QFI) launches a new programme intended to assist medical device manufacturers in the development of environment-friendly, eco-designed and green medical devices.   “We think it is … Continue reading “Leadership through eco-friendly medical device manufacturing and waste management: new regulatory service available from QFI”

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29 January 2021

The newly developed Environmental Similarity Index can help medical device companies gain insights into their waste management

Haroon Atchia, CEO and co-founder of the London-based medical device regulatory consultancy Quality First International, has written a Technical Paper on medical device waste management introducing the notion of an Environmental Similarity Index (ESI). The … Continue reading “The newly developed Environmental Similarity Index can help medical device companies gain insights into their waste management”

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