Quality First International

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Welcome to Quality First International

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.

Download our company brochure now to see all of the services offered by Quality First International.

CONSULTING SERVICES

FDA Clearance

CE Mark

QMS

Regulatory Assurance

Device Registration

Clinical Trials

Regulatory Remediation

Scientific & Clinical Literature Examination

LATEST PUBLICATIONS

Decoding the ASEAN Draft Medical Device Directive

Critical examination of the WHO model regulatory program for medical devices

Decoding European Union Medical Device proposal Regulation

Inadequacies of the European regulatory framework for breast implants

LATEST NEWS

9 May 2016

REGULATORY CASE STUDY: THERANOS
Is FDA evidence sufficient and credible to corroborate allegations that Theranos, Inc. violated medical device regulations?

15 May 2015

FREE ARTICLE
Utility of ALARP principle in application of precautionary principle for purposes of medical device regulatory decision (April 2012).

7 January 2015

PRESS RELEASE
Manufacturers must understand the implications of the 2014 update to ISO 11135 on the sterilisation of medical devices using ethylene oxide - a new paper written by Haroon Atchia identifies and assesses the changes introduced by ISO 11135:2014.

7 January 2015

NEW ARTICLE PUBLISHED
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written an article on the changes to ISO 11135 on the sterilisation of medical devices by exposure to ethylene oxide. The paper entitled Critical examination of changes to ISO 11135 on sterilisation of medical devices by exposure to ethylene oxide examines the standard in an attempt to understand the implications for medical device manufacturers currently using ISO 11135-1:2007 and those seeking to apply ISO 11135 for the first time.


NEWS FROM 2014

12 November 2014

PRESS RELEASE
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written an article which explores the content of Recommendation 2013/473/EU and exposes areas of possible abuse that could lead to the exploitation of economic operators in the field of medical devices.

3 September 2014

PRESS RELEASE
A new paper written by Haroon Atchia questions the adequacy of EN ISO 13485: 2012 and raises the question of whether the standard is more focused on quality assurance registration schemes than meeting current European regulations.

9 January 2014

NEW REPORT
"Explanted Poly Implant Prosthése (PIP) Breast Implants - An Independent Examination" by Haroon Atchia (129 pages).

9 January 2014

PRESS RELEASE
International medical device expert, Haroon Atchia, examines the investigation and analysis conducted by the Competent Authority in  Sweden on explanted Poly Implant Prosthése (PIP) breast implants.


NEWS FROM 2013

16 September 2013

REMEDIATION SERVICES
Haroon Atchia, CEO & Technical Director of QFI, has become a Member of the Society of Corporate Compliance and Ethics.

12 September 2013

NEW REPORTS
QFI has published two new, comprehensive electronic reports:

11 June 2013

FREE ARTICLE
Etude du projet de directive sur les dispositifs médicaux de l'ASEAN by Haroon Atchia, CEO and Technical Director, QFI.

11 June 2013

FREE ARTICLE
Prüfung des Entwurfs der ASEAN Medizinprodukterichtlinie by Haroon Atchia, CEO and Technical Director, QFI.

23 May 2013

PRESS RELEASE
New ASEAN draft Medical Device Directive: Will it create the hoped for economic boost for the region?

13 May 2013

FREE ARTICLE
Examination of the ASEAN draft Medical Device Directive by Haroon Atchia, CEO and Technical Director, QFI.

13 May 2013

FREE ARTICLE
Risk analysis - application to biological safety assessment by Haroon Atchia, CEO and Technical Director, QFI.

25 April 2013

PRESS RELEASE
Decoding European Union Medical Device proposal Regulation – What is new, what has been updated, what has been changed, which opportunities have been missed?. To order your copy click here.

18 April 2013

FREE ARTICLE
Manufacturers in limbo because of placement on the market obligations by Haroon Atchia, CEO and Technical Director, QFI.

20 March 2013

FREE ARTICLE: Critical examination of The Clinical Trials Act 2011 by Haroon Atchia, CEO and Technical Director, QFI.

15 March 2013

FREE ARTICLE
Examination of the report on the functioning of the Medical Devices Directive (93/42/EC of 14 June 1993) Final Report 05-06-2002 by Haroon Atchia, CEO and Technical Director, QFI.

27 February 2013

FREE ARTICLE
Best practice advice for approaching risk and evaluation by Haroon Atchia, CEO and Technical Director, QFI.

27 February 2013

FREE ARTICLE: Clinical data by Haroon Atchia, CEO and Technical Director, QFI.

25 February 2013

FREE ARTICLE: Examination of Poly Implant Prothèse (PIP) silicone breast implant retrieval study by Swarts et al (2012) by Haroon Atchia, CEO and Technical Director, QFI.

18 February 2013

FREE ARTICLE
Process challenge devices for demonstration of sterilisation effectiveness by Haroon Atchia, CEO and Technical Director, QFI.


NEWS FROM 2012

26 December 2012

Press release: An in-depth analysis of the inadequacies of the European regulatory framework for breast implants. To order your copy click here.

27 November 2012

FREE white paper download: 'Correspondence between EN ISO 14971 and Council Directive 93/42/EEC'.

5 October 2012

BOOK SALE - for a limited time only, you may purchase a copy of Biological Safety & European Medical Device Regulations by JJB Tinkler, UK Department of Health for only £49.99 plus postage, saving you 33% on the RRP.

25 September 2012

How adequate is the European regulatory framework for breast implants? - Haroon Atchia from Quality First International examines the regulatory framework that is at the core of one of the biggest current international health scandals

Le cadre réglementaire européen pour les implants mammaires est-il adéquat? - Haroon Atchia de Quality First International examine le cadre réglementaire qui est au cœur de l'un des plus grands scandales sanitaires internationales actuelles

Wie geeignet ist der europäische Rechtsrahmen für Brustimplantate? - Haroon Atchia von  Quality First International untersucht den Rechtsrahmen, der im Zentrum eines der größten aktuellen internationalen Gesundheits-Skandale steht.

17 May 2012

Haroon Atchia from QFI evaluates the impact of the new European medical device vigilance guidelines (MEDDEV 2.12-1 rev 7) on manufacturers of medical devices.

15 May 2012

QFI launches a NEW one-day seminar on the principles and practice of remedial action: non-conformity, corrective and preventive actions.

6 February 2012

Commission Publishes Update of MEDDEV 2.12/2 on Post Market Clinical Follow-Up (PMCF) Studies.


NEWS FROM 2011

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.


NEWS FROM 2010

22 November 2010

A Critical Examination of MEDDEV 2.7.1 rev 3

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

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


NEWS FROM 2009

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

27 March 2009

Download a FREE white paper comparing the Medical Device Directive and the Toys Directive

16 February 2009

Download a FREE white paper on the transposition of Amending Directive 2007/47/EC

28 January 2009

All product technical documentation for marketed medical devices must be revised by March 2010 to comply with Directive 2007/47/EC

19 January 2009

Extended deadline for registration of medical devices in Italy

 

 

 

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