LATEST NEWS

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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5 October 2020

Quality First International updates post-Brexit UK Responsible Person Programme for medical device manufacturers

After a recent update of the UK MHRA’s guidance on “Regulating medical devices from 1 January 2021“, the British medical device regulatory consultancy Quality First International has updated its UK Responsible Person Programme, which offers … Continue reading “Quality First International updates post-Brexit UK Responsible Person Programme for medical device manufacturers”

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31 January 2020

STANDARDS SEARCH PROGRAMME

QFI offers a unique Standards update and review service for medical devices through our Standards Search Programme that ensures rigorous and accurate conformity to Standards is achievable.

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