Medical Device Regulation and Big Data

Event Details

When

Monday 16th Apr - Monday 16th Apr
1:15 pm - 4:00 pm
2018-04-16 13:15:00 2018-04-16 16:00:00 Europe/London Medical Device Regulation and Big Data Seminar Room 1.06 Maurice Keyworth Building Leeds University Business School University of Leeds LS6 1AN

Where

Seminar Room 1.06 Maurice Keyworth Building Leeds University Business School University of Leeds LS6 1AN

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Medical Device Regulation and Big Data

Mark Wasmuth (CEO, GMDN Agency) and Dr Barry Daniels (Technical Lead, GMDN Agency) will give a talk about their work on the Global Medical Device Nomenclature as a dynamic yet harmonised system of device classification. The Global Medical Device Nomenclature (GMDN) is a list of generic names for medical device products used in the diagnosis, prevention, monitoring, and treatment of disease.

The main purpose of the GMDN is to provide regulators, health care providers, manufacturers and others with a naming system that can be used to exchange medical device information and support patient safety. The GMDN is a very dynamic classification system, which changes on an almost daily basis as new devices come on the market. The GMDN Agency is the non-profit organisation that is responsible for the ongoing maintenance of the GMDN.

The speakers will focus in particular on their experience of working with the US-American FDA and European counterparts on the implementation of new medical device regulation, including unique device identification (UDI) systems designed to identify devices through distribution and use.

They will discuss some of the implications of the introduction of UDI systems for manufacturers, healthcare providers and researchers. The talk will be followed by an open discussion of regulatory change and the advent of big data in medical device regulation.

For more information, visit: https://business.leeds.ac.uk/about-us/article/ideas-in-practice-seminar-5/

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