New Medical Device Standard QFIS 002:2022 on Medical Device Apps Just Published by Quality First International
The new sector-specific standard is a technical specification to assist manufacturers, developers and technical assessorsdesign, develop and evaluate medical device apps. - December 21, 2022
Quality First International Has Published Indispensable Analysis of Europe’s Current Guidance on Clinical Evaluations, MEDDEV 2.7/1, Revision 4
London-based, medical device regulatory consultancy, Quality First International has published an extensive handbook on the clinical evaluation guidance document from the European Commission, MEDDEV 2.7/1, Revision 4. - October 06, 2018
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. - December 07, 2017
A Regulatory Case Study on the Theranos, Inc. Case Written by Quality First International Investigates Allegations Promulgated
Is FDA evidence sufficient and credible to corroborate allegations that Theranos, Inc. violated medical device regulations? - May 12, 2016
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. - January 15, 2015
Is There Potential for Abuse and Mis-Use of Recommendation 2013/473/EU by Notified Bodies and What Are the Implications for Medical Device Economic Operators?
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written an article which explores the content of the Recommendation and exposes areas of possible abuse that could lead to the exploitation of economic operators in the field of medical devices. - November 14, 2014
Decoding European Union Medical Device Proposal Regulation –what is New, What Has Been Updated, What Has Been Changed, Which Opportunities Have Been Missed?
The internationally known Medical Device regulatory expert, Haroon Atchia has published the first fundamental and critical examination of the proposal Regulation. - May 01, 2013
Now Available: Inadequacies of the European Regulatory Framework for Breast Implants – an In-Depth Analysis
The internationally known Medical Device regulatory expert, Haroon Atchia has published an objective analysis of the regulatory framework that is at the core of one of the biggest current international health scandals. - December 28, 2012
Haroon Atchia from Quality First International Examines the Regulatory Framework That is at the Core of One of the Biggest Current International Health Scandals
The European Union continues to deal with a scandal about breast implants made and placed on the market with the CE mark of conformity by the French company Poly Implant Prothèse (PIP). Thousands of women have undergone difficult and potentially risky explant procedures based on physician... - September 27, 2012
How the New European Medical Device Vigilance Guidelines (MEDDEV 2.12-1 rev 7) Will Affect Manufacturers
Haroon Atchia from QFI evaluates the impact of the changes introduced by the revision on manufacturers of medical devices. - May 23, 2012
Comments on the Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe from QFI
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 entitled "A Confusing Lack of Regulatory... - May 03, 2011
Introduction to the Fundamentals of Classification: Haroon Atchia from QFI Writes New Guidance Document Published by Global Regulatory Press
Haroon Atchia from Quality First International has written a new guidance document entitled “Principles and Practice of Medical Device Classification.” - October 23, 2009
Deadline for Re-Registration of Medical Devices and IVDs in the UK is 31 May 2009
The European Union (EU) has revised the various Medical Device Directives regulating how products are approved for sale in the 27 EU Member States. Quality First International (QFI), the London-based medical devices consultancy, is alerting all device manufacturers to the important implications for marketed devices. - April 19, 2009
All Product Technical Documentation for Marketed Medical Devices Must be Revised by March 2010 to Comply with Directive 2007/47/EC – One Year Left
Quality First International has formed a task force of technical experts to help companies attain or maintain compliance under the new requirements. - February 04, 2009
Extended Deadline for Registration of Medical Devices in Italy
Quality First International previously issued an alert to all medical device companies intending to sell their medical device in Italy beyond 31 December 2008: Italy introduced various changes in healthcare regulations, among which is the need for any medical device placed on the Italian market to... - January 22, 2009
Call for Submission of EC Classification Problems Relating to Medical Devices
Quality First International invites manufacturers to submit their experiences of classification problems involving medical devices regulated under Directive 93/42/EEC, in complete confidence. - December 18, 2008
Regulatory Alert: New Challenges in Clinical Data Evaluation for Medical Device Manufacturers Following Amendment of the Medical Devices Directive
The amendments to Council Directive 93/42/EEC relating to clinical data, which will come into force on 21 March 2010, are already affecting manufacturers of medical devices in Europe. Quality First International is alerting medtech companies who have not yet acted on these changes, which are... - November 01, 2008
Quality First International Alerts Clients and Medtech Companies: Registration Requirements in Italy
Regulatory alert: Mandatory Registration of Class I, IIa, IIb and III Medical Devices in Italy – Quality First International alerts clients and medtech companies. - October 30, 2008