Tuesday, November 29th, 2011
A new regulatory tool for medical device companies, the e-Zassi software, is now live on the Qmed website. Qmed, a UBM Canon site, is a qualified medical device supplier directory, search engine and industry resource. E-Zassi is an Innovation Management software platform for the medical device industry.
Part of the tool, ...
Posted in Regulation | Add Comment »
Tuesday, August 23rd, 2011
Earlier this month, a group of EU medical device Notified Bodies signed a voluntary Code of Conduct designed to improve the consistency and competency of uniform bodies. The code was endorsed by the members of the Association of Notified Bodies (TEAM-NB) in April of this year.
The group of Notified Bodies ...
Posted in Standards, medtechinsider | Add Comment »
Wednesday, March 23rd, 2011
A survey of medical technology industry associations conducted by Eucomed has identified several significant barriers that confront small and medium enterprises (SMEs) at the EU level. The barriers include inconsistent application of EU regulations, requirements that inhibit the commercialisation of new technologies, and limited access to R&D funding programmes and ...
Posted in EU Regulatory | Add Comment »
Monday, September 15th, 2008
On 8 May, the European Commission (EC) launched a public consultation on the need to develop a new framework for the regulation of medical devices. It cited a number of reasons for engaging this dialogue, notably inconsistent safeguards for public health among member states, new technologies that the present directives ...
Posted in medtechinsider | Add Comment »
Sunday, July 27th, 2008
The Medicines and Healthcare products Regulatory Agency, the UK
competent authority, has published an updated version of guidance relating to clinical investigations. The document applies to manufacturers that intend to carry out clinical investigations in the United Kingdom.
The document covers all aspects of performing and reporting clinical investigations in the United ...
Posted in medtechinsider | Add Comment »
