Dec 19, 2022
The new sector-specific standard is a technical specification to assist manufacturers, developers and technical assessors design, develop and evaluate medical device apps.
Dec 05, 2017
Haroon Atchia - CEO of the London-based medical device regulatory consultancy Quality First International - has written a profound analysis on the controversial standard EN ISO 14630 on non-active surgical implants whose latest version from 2012 is...
May 23, 2013
The internationally-renowned medical device regulatory expert, Haroon Atchia, has written a critical examination of the draft ASEAN Medical Device Directive
Apr 29, 2013
The internationally known Medical Device regulatory expert, Haroon Atchia has published the first fundamental and critical examination of the proposal Regulation
Dec 26, 2012
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
Sep 25, 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
Apr 17, 2009
London, 17 April 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.
Feb 02, 2009
Quality First International has formed a task force of technical experts to help companies attain or maintain compliance under the new requirements of Directive 2007/47/EC
Jan 20, 2009
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
Dec 16, 2008
Quality First International invites manufacturers to submit their experiences of classification problems involving medical devices regulated under Directive 93/42/EEC, in complete confidence