Workshop on safety and efficacy for medical devices

At the request of the Global Harmonization Task Force (GHTF), ISO is organizing a workshop entitled “International Standards to achieve worldwide safety and efficacy for medical devices” on 4 October 2007 in Washington DC, USA.

The workshop will consider the integration of risk management with a medical device’s overall manufacturing quality management system.  This approach, outlined in the GHTF guidelines and relying on International Standards to support essential principles, could help to eliminate redundancy and reduce production costs.  

Among the subjects covered will be the link and synergy with the World Trade Organization, when key general issues which apply to medical devices will be explored.  Finally, the workshop will address the topic of “Regulations and beyond”. With standards as their basis, where does the future of regulations lead to, and what are the next steps in this crucial field for global commerce?  

An eminent panel of speakers covering several ISO Technical Committees will introduce conformity assessment (CA) and its role in ensuring product safety, as well as the need for CA to consider risk when defining its processes. Presentations will also address the latest in sterilization standards, health informatics, risk reduction through standards promoting correct diagnostic information and more.

The Global Harmonization Task Force was conceived to encourage convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices, promoting technological innovation and facilitating international trade.  GHTF has a Memorandum of Understanding with ISO/TC 194, Biological evaluation of medical devices and ISO/TC 210, Quality management and corresponding general aspects for medical devices.