CONSULTING SERVICES

Welcome to Quality First International
a medical devices consultancy

Quality First International is a leading, global medical devices consultancy, with extensive insight and business know-how in the medical devices regulatory field. QFI is committed to solving your regulatory, technical and compliance challenges to enable your medical device to enter the global marketplace. With our technical expertise, accuracy and confidentiality we can help you be the first to market, reinforce the approval of your medical device, resolve any compliance issues and solve other problems encountered during the regulatory approval of your medical device.

Latest News...

7 December 2011

Medical Device Classification from your desktop – Quality First International has developed an online system for easy self-classification of medical devices under the European system.

14 November 2011

Haroon Atchia has written a comprehensive update of A Beginners' Guide to the European Medical Devices Directive (MDD), which has been published by Global Regulatory Press.

7 June 2011

Popularity and Ease of Own-brand Labelling Created by a Confusing Lack of Regulatory Provisions Promotes Violation. Haroon Atchia from QFI writes a new guidance document published by Global Regulatory Press.

28 April 2011

A Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe. No regulations on the own-brand labelling of medical devices exist in the European Union, which is the essence of the problem elucidated in an article published in the May 2011 issue of the Journal of Medical Device Regulation (JMDR). The article is written by Haroon Atchia, CEO of Quality First International and member of the JMDR's Editorial Advisory Board.

19 April 2011

Learn all about the Principles of Ethylene Oxide Sterilisation. Providing indispensable hands-on knowledge for professionals involved in sterilisation process design, operation, control, approval and assessment, QFI launches a new one-day training course examining the principles of ethylene oxide sterilisation.

22 November 2010

A Critical Examination of MEDDEV 2.7.1 rev 3
Haroon Atchia from Quality First International (QFI) has written a new article entitled "A Critical Examination of MEDDEV 2.7.1 rev 3". The article, published by Global Regulatory Press, examines the content of MEDDEV 2.7.1 Rev 3 (December 2009), entitled "Clinical evaluation: A guide for manufacturers and Notified Bodies", which revises the April 2003 version of the MEDDEV, apparently aligns with Global Harmonisation Task Force Guidance SG5/N2R8: 2007, Clinical evaluation, and accommodates amending Directive 2007/47/EC. Further to examining the content of the revised MEDDEV guidance, Haroon Atchia’s article questions its motives, utility, impartiality, legal status and method of preparation. The article was published in the August 2010 issue of the Journal of Medical Device Regulation.

23 September 2010

QFI has developed a 15-minute video entitled "An Introduction to the European Regulatory Process for Medical Devices", which you can watch on YouTube at www.youtube.com/watch?v=zUAEULMdqXk.

21 April 2010

Changes to obligation concerning labelling of medical devices containing phthalates
We are alerting our clients about changes to obligation concerning labelling of medical devices containing phthalates. The obligation became Law on 21 March 2010, consequently all products Placed on the Market and Put into Service (ie, supplied from 21 March 2010) must comply otherwise it is an Offence. The restrictions concern devices or parts (components or constituents thereof) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances.

QFI can help to examine the biological safety risks of phthalate in a medical device, explore relevant intolerance and toxicity aspects and formulate the required documentation to support continued Placement of product on the market.

In the event of queries, or for an applicable form, please do not hesitate to contact the following:
USA: Tom Alexandris +1-770-656-5513
EU: Rachid Hattab +44-208-221-2361

13 April 2010

New requirements to register medical devices in Greece
We are alerting our clients about new requirements for registration of medical devices in Greece. The new regulations became law on 21 March 2010, meaning that any product not registered according to the new requirements will be proscribed, regardless of whether it bears the CE Marking of Conformity or whether it has been registered previously under old law.

QFI can commence the registration with the local authorities in Greece on your behalf speedily on receipt of your instruction.

In the event of queries, or for an applicable form, please do not hesitate to contact the following:
USA: Tom Alexandris +1-770-656-5513
EU: Rachid Hattab +44-208-221-2361

10 November 2009

Free white paper examining the European Commission's Interpretative Document on the relation between the revised Directives 90/385/EEC and 93/42/EEC and Directive 2006/42/EC on machinery

10 November 2009

Free white paper examining the European Commission's Interpretative Document on the relation between the revised Directive 93/42/EEC and Directive 90/686/EEC on personal protective equipment

10 November 2009

Free white paper examining the European Commission's Interpretative Document on amending Directive 2007/47/EC

21 October 2009

Introduction to the fundamentals of classification: Haroon Atchia from QFI writes new guidance document

1 May 2009

Deadline for registration of medical devices in Italy has been postponed from 30 April 2009 to 31 December 2009

17 April 2009

Deadline for re-registration of medical devices and IVDs in the UK is 31 May 2009