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.
8 March 2018
Manufacturers are advised to establish formal procedures to determine if
an accessory or other component of a medical-electrical equipment is ‘applied’
An article published by London-based medical device regulatory expert Haroon Atchia explores the concept of an ‘applied part’, as described and defined by the standard on medical-electrical equipment safety, and not by legislation or regulation. Read more & purchase
28 February 2018
What is the meaning of the terms disability and handicap in the European
medical device legislation?
An article published by London-based medical device regulatory consultancy Quality First International considers the terms “disability” and “handicap”, analyses and evaluates their differences in the context of available medical device legislation, identifies information asymmetry, and formulates improvements and recommendations. Read more
27 February 2018
British medical device expert proposes implant rules to define a
non-active surgical implant as optimum or ideal
An article written by an international expert in US and European medical device regulations, Mr Haroon Atchia, explores the fundamental properties and characteristics of non-active surgical implants, and proposes implant rules from which concepts of optimum physiological function and implant potential, respectively, are proposed. Read more
30 January 2018
EU regulation on European standardisation is insufficient to ensure
independence from special interests of standardisation bodies, says British
medical device expert
An article written by an international expert in US and European medical device regulations, Mr Haroon Atchia, examines Regulation (EU) No 1025/2012 on European standardisation critically, from its prime motivation to institutional elements of legitimation of standards in the context of the so-called New Approach. Read more
4 December 2017
Understanding the black sheep of standards: An analysis of EN ISO 14630 on
non-active surgical implants and practicalities of its application
An eBook on the standard EN ISO 14630 written by Haroon Atchia analyses the controversial standard on non-active surgical implants whose latest version from 2012 is considered non compliant with the relevant legal requirements (Article 10. 6 of Regulation (EU) No 1025/2012) by the European Commission. Read more
4 January 2017
Update on the timings for the new European Regulations on medical devices and IVDs
The European Commission presented the latest timelines for the new Regulations on medical devices and in vitro diagnostics (IVDs) at the Eudamed Steering Committee meeting on 14 December 2016. Formal adoption of the new Regulations is currently foreseen for the spring of 2017. Commission officials confirmed that the new Regulations should be published in the Official Journal at the end of the first quarter of 2017. Entry into force will be 20 days after the date of publication. The date of application will be three years later for medical devices and five years later for IVDs. Some Articles will apply earlier than others to allow for a smooth implementation of the new Regulations.
QFI will keep clients updated on the official publication schedule. Please contact email@example.com in the meantime for any specific queries or support.
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
Utility of ALARP principle in application of precautionary principle for purposes of medical device regulatory decision (April 2012).
7 January 2015
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
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
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
"Explanted Poly Implant Prosthése (PIP) Breast Implants - An Independent Examination" by Haroon Atchia (129 pages).
9 January 2014
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
Haroon Atchia, CEO & Technical Director of QFI, has become a Member of the Society of Corporate Compliance and Ethics.
12 September 2013
QFI has published two new, comprehensive electronic reports:
- Decoding the ASEAN Draft Medical Device
- Critical examination of the WHO model regulatory program for medical devices: an international guide and how it could be used to shape and define regulation of medical devices
11 June 2013
Etude du projet de directive sur les dispositifs médicaux de l'ASEAN by Haroon Atchia, CEO and Technical Director, QFI.
11 June 2013
Prüfung des Entwurfs der ASEAN Medizinprodukterichtlinie by Haroon Atchia, CEO and Technical Director, QFI.
23 May 2013
13 May 2013
Examination of the ASEAN draft Medical Device Directive by Haroon Atchia, CEO and Technical Director, QFI.
13 May 2013
Risk analysis - application to biological safety assessment by Haroon Atchia, CEO and Technical Director, QFI.
25 April 2013
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
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
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
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
Process challenge devices for demonstration of sterilisation effectiveness by Haroon Atchia, CEO and Technical Director, QFI.
NEWS FROM 2012
26 December 2012
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
NEWS FROM 2011
7 December 2011
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
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
10 November 2009
10 November 2009
21 October 2009
1 May 2009
17 April 2009
27 March 2009
16 February 2009
28 January 2009
19 January 2009
Copyright © 2004-2017 Quality First International. All rights reserved.