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EU Medical Device In Vitro Diagnostic Medical Device Regulations November 2017

The EU’s Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) came into force on 25 May 2017 and will replace the EU’s current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). Manufacturers of currently-approved medical devices will have a transition time of three years until May 26th 2020 to meet the […]

ISO 9004 is Getting a Facelift

ISO 9004 is the forthcoming standard for managing the sustained success of an organisation.  It is to be used as a tool to extend the benefits of ISO 9001:2015, by ensuring organisations can consistently meet the relevant needs and expectations of their interested parties, in a balanced way, over the long term.  Relevant interested parties […]

Data Protection Day 2016

Today marks the 10th Anniversary of the signing of the Council of Europe’s Convention 108 for the Protection of Individuals. The convention referred to the automatic processing of personal data, which has been the cornerstone of data protection in Europe and beyond for the last 30 years. Data Protection Day is celebrated globally on the […]