PR.com Press Releases: Quality First International News https://www.PR.com/ Latest news releases from PR.com for Quality First International. Sat, 17 Oct 2026 02:02:31 -0400 © 2026 PR.com 60 en-us https://www.PR.com/images/logo_white.jpg PR.com Press Releases: Quality First International News https://www.PR.com/ 68 69 PR.com provides press release distribution, and is a unique directory of businesses, products and services. Find full company profiles. https://www.pr.com/press-release/875404 New Medical Device Standard QFIS 002:2022 on Medical Device Apps Just Published by Quality First International Wed, 21 Dec 2022 03:00:00 -0500 The new sector-specific standard is a technical specification to assist manufacturers, developers and technical assessorsdesign, develop and evaluate medical device apps. [PR.com] https://www.pr.com/press-release/875404 Quality First International https://www.pr.com/press-release/766526 Quality First International Has Published Indispensable Analysis of Europe’s Current Guidance on Clinical Evaluations, MEDDEV 2.7/1, Revision 4 Sat, 06 Oct 2018 03:00:00 -0400 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. [PR.com] https://www.pr.com/press-release/766526 Quality First International https://www.pr.com/press-release/738093 Understanding the Black Sheep of Standards: An Analysis of EN ISO 14630 on Non-Active Surgical Implants and Practicalities of Its Application Thu, 07 Dec 2017 03:00:00 -0500 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. [PR.com] https://www.pr.com/press-release/738093 Quality First International https://www.pr.com/press-release/670452 A Regulatory Case Study on the Theranos, Inc. Case Written by Quality First International Investigates Allegations Promulgated Thu, 12 May 2016 16:34:53 -0400 Is FDA evidence sufficient and credible to corroborate allegations that Theranos, Inc. violated medical device regulations? [PR.com] https://www.pr.com/press-release/670452 Quality First International https://www.pr.com/press-release/600817 Manufacturers Must Understand the Implications of the 2014 Update to ISO 11135 on the Sterilisation of Medical Devices Using Ethylene Oxide Thu, 15 Jan 2015 03:00:00 -0500 A new paper written by Haroon Atchia identifies and assesses the changes introduced by ISO 11135:2014. [PR.com] https://www.pr.com/press-release/600817 Quality First International https://www.pr.com/press-release/592024 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? Fri, 14 Nov 2014 03:00:00 -0500 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. [PR.com] https://www.pr.com/press-release/592024 Quality First International https://www.pr.com/press-release/488393 Decoding European Union Medical Device Proposal Regulation –what is New, What Has Been Updated, What Has Been Changed, Which Opportunities Have Been Missed? Wed, 01 May 2013 03:00:00 -0400 The internationally known Medical Device regulatory expert, Haroon Atchia has published the first fundamental and critical examination of the proposal Regulation. [PR.com] https://www.pr.com/press-release/488393 Quality First International https://www.pr.com/press-release/463479 Now Available: Inadequacies of the European Regulatory Framework for Breast Implants – an In-Depth Analysis Fri, 28 Dec 2012 03:00:00 -0500 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. [PR.com] https://www.pr.com/press-release/463479 Quality First International https://www.pr.com/press-release/443648 Haroon Atchia from Quality First International Examines the Regulatory Framework That is at the Core of One of the Biggest Current International Health Scandals Thu, 27 Sep 2012 03:00:00 -0400 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 recommendations while physicians have had only contradictory and confusing guidance from governments and regulatory agencies on [PR.com] https://www.pr.com/press-release/443648 Quality First International https://www.pr.com/press-release/414558 How the New European Medical Device Vigilance Guidelines (MEDDEV 2.12-1 rev 7) Will Affect Manufacturers Wed, 23 May 2012 03:00:00 -0400 Haroon Atchia from QFI evaluates the impact of the changes introduced by the revision on manufacturers of medical devices. [PR.com] https://www.pr.com/press-release/414558 Quality First International https://www.pr.com/press-release/317572 Comments on the Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe from QFI Tue, 03 May 2011 11:07:13 -0400 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 Provisions for Own-Brand Labelling of Medical Devices in Europe" and is written by Haroon Atchia, a member of the [PR.com] https://www.pr.com/press-release/317572 Quality First International https://www.pr.com/press-release/187457 Introduction to the Fundamentals of Classification: Haroon Atchia from QFI Writes New Guidance Document Published by Global Regulatory Press Fri, 23 Oct 2009 03:00:00 -0400 Haroon Atchia from Quality First International has written a new guidance document entitled “Principles and Practice of Medical Device Classification.” [PR.com] https://www.pr.com/press-release/187457 Quality First International https://www.pr.com/press-release/146365 Deadline for Re-Registration of Medical Devices and IVDs in the UK is 31 May 2009 Sun, 19 Apr 2009 03:00:00 -0400 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. [PR.com] https://www.pr.com/press-release/146365 Quality First International https://www.pr.com/press-release/130029 All Product Technical Documentation for Marketed Medical Devices Must be Revised by March 2010 to Comply with Directive 2007/47/EC – One Year Left Wed, 04 Feb 2009 03:00:00 -0500 Quality First International has formed a task force of technical experts to help companies attain or maintain compliance under the new requirements. [PR.com] https://www.pr.com/press-release/130029 Quality First International https://www.pr.com/press-release/127639 Extended Deadline for Registration of Medical Devices in Italy Thu, 22 Jan 2009 03:00:00 -0500 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 be registered on a central, coded database (Repertorio) according to two Italian Decrees issued in February 2007 and on 20 [PR.com] https://www.pr.com/press-release/127639 Quality First International https://www.pr.com/press-release/122408 Call for Submission of EC Classification Problems Relating to Medical Devices Thu, 18 Dec 2008 03:00:00 -0500 Quality First International invites manufacturers to submit their experiences of classification problems involving medical devices regulated under Directive 93/42/EEC, in complete confidence. [PR.com] https://www.pr.com/press-release/122408 Quality First International https://www.pr.com/press-release/113986 Regulatory Alert: New Challenges in Clinical Data Evaluation for Medical Device Manufacturers Following Amendment of the Medical Devices Directive Sat, 01 Nov 2008 03:00:00 -0400 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 primarily contained in Article 15/Annex X of Directive 93/42/EEC, to familiarise themselves with the extended requirements and take [PR.com] https://www.pr.com/press-release/113986 Quality First International https://www.pr.com/press-release/110891 Quality First International Alerts Clients and Medtech Companies: Registration Requirements in Italy Thu, 30 Oct 2008 10:46:51 -0400 Regulatory alert: Mandatory Registration of Class I, IIa, IIb and III Medical Devices in Italy – Quality First International alerts clients and medtech companies. [PR.com] https://www.pr.com/press-release/110891 Quality First International