The Notified Bodies around the world are preparing themselves for the new upcoming MDD regulations recast. The regulation was published on 26th September 2012 includes the new EU regulations on all medical devices. The final regulation is likely to be released in 2014. The changes would reflect: v The new EU regulation structure and system … Read more
QMS can help your business to: 1) Achieve greater consistency in the activities involved in providing products or services. 2) Reduce expensive mistakes. 3) Increase efficiency by improving use of time and resources. 4) Improve customer satisfaction. 5) Market your business more effectively. 6) Exploit new market sectors and territories. 7) Manage growth more effectively … Read more
Manfred Koehler of the European Commission (in charge of European regulation for medical devices, SANCO Eurocrat and lawyer) joined the European Association of Authorised Representative (EAAR) on 26th September 2013. He went straight to the point that the European Commission consider the regulatory responsibility of Authorised Representatives (AR) for self-certified medical devices to be on … Read more
John Adcock – Managing Director Advena Ltd will be speaking at the ‘Medilink Design & Innovation Masterclass’ at Medilink West Midlands, Medical Technologies Innovation Centre, 4 Greenfield Crescent, Edgbaston, Birmingham, B15 3BE on Wednesday 25th September – 9:30am – 4:00pm John will be sharing his experience and providing good practical advice on Regulatory considerations at the … Read more
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