Welcome to Quality First International
leading global medical devices consultancy
With extensive insight and business know-how in the global medical devices regulatory field, QFI’s consulting services are designed to assist you at any stage of your business with everything from product design, clinical evaluation, including clinical development and investigation design, research and monitoring to market entry, distributor search, sourcing, and market research to regulatory strategy and compliance, product registration, authorised representation, importer service, plus all requirements of market surveillance and quality compliance all over the world.
Our technical expertise, specialist knowledge accuracy and confidentiality can help you to accelerate market entry, reinforce approval of your medical device and resolve compliance issues or challenges encountered during regulatory approval processes, including enforcement case and litigation.
OVERVIEW OF QFI SERVICES
Solutions for Your Regulatory Issues
QFI has critical insight, expertise, business knowledge and experience with all types of medical devices and certain other regulatory-related disciplines. This is reflected in the scope of our core services, including:
- 1Medical Device regulatory support and standards compliance
- 2International Representative Programme
- 3Biological Safety Programme
- 4Quality Management Systems, audits and inspections
- 5Microbiology Advisory Program
- 6Medical device registration
- 7EU Authorised Representation
- 8Clinical Trials Program
- 9UK Responsible Person service
- 10Official Importer service
- 11Medical device environmental waste management & sustainability
- 12EU Authorised Data Protection Representative Programme (EUDPRP)
- 13StandardSearch Programme
- 14Medical device market surveillance
LATEST NEWS
22 June 2021
New article on the design principles of electrical surgical instrumentsQuality 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”
9 June 2021
New Guidance: Understand how to apply general personal data protection to medical devices to avoid non-compliance and finesQuality 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”
4 May 2021
New medical device standard QFIS 001:2021 on safety-related functions and activities just published by Quality First InternationalThe 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”
1 March 2021
Leadership through eco-friendly medical device manufacturing and waste management: new regulatory service available from QFIThe 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”
29 January 2021
The newly developed Environmental Similarity Index can help medical device companies gain insights into their waste managementHaroon 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”
5 October 2020
Quality First International updates post-Brexit UK Responsible Person Programme for medical device manufacturersAfter 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”