1st EFOMP-COCIR webinar on IEC standards

Publication Date: Feb 20th, 2021 23:08, Category: EFOMP Announcements

The 1st EFOMP-COCIR Webinar will take place Friday March 19th at 12:00 AM CET.

Webinar: "IEC overview: the importance for the MPE community"

The webinar is available on EFOMP e-learning platform!

Standards play a crucial part in our lives. In healthcare, standards have an indispensable role for the proper functioning of medical devices, for correct transmission of information, for therapy, for monitoring and support in treatment, and much more. Thus, standards help manufacturers to produce safe medical devices with constant high quality and, as such, help competent authorities to ensure that medical devices in their country provide the performance they want for their citizens.

All stakeholders are invited to participate in the drafting of international standards so that the requirements in these standards get the widest possible support. The rules under which standards are developed in IEC reflect six principles: openness, transparency, impartiality and consensus, effectiveness and relevance, coherence, and development dimension. This is to make sure that the result reflects the state of the art, regardless whether the experts are from industry, medical practice, test institutes, or authorities. Decisions come through voting by the National Committees. Having multiple rounds of commenting, redrafting, and voting, the standards mature to a level that is relevant for all stakeholders.

The webinar will provide a brief introduction into the functioning and structure of IEC, the importance of standards both for manufacturers and Medical Physics Experts and the advantages stemming from a stricter cooperation.

The speakers (Remy Klausz and Regina Geierhofer) will focus on:

• IEC functioning, composition and participation
• Different kind of standards and their use
• The standardization process, from the submission of a proposal to the publication of the final  standard
• Standards of interest for the MPE community
• Interactions between EU legislation, EURATOM Directives, national legislation and standards

 

Panelists for the webinar include Alberto Torresin (EFOMP School Chair) and Loredana Marcu (European Matters Committee Chair).

Regina Geierhofer is currently the secretary of IEC TC62, SC62B, SC62C. She has an experience of over 20 years in the standardization area on the national and international area. She still holds a ASQ certification as lead auditor for medical devices and information security. After her graduations in applied chemistry and applied mathematics, Ms Geierhofer worked a decade at an university hospital, with a focus on radiology, nuclear medicine and pathology, before she moved to regulatory affairs positions in the industry.

 

 

 

 

 Remy Klausz is a Principal Engineer at Womens’ Health division of GE Healthcare. Since his Engineering degree in Physics at ESPCI (Paris) he continuously worked for the optimization of Image Quality and dose of diagnostic imaging equipment, from the 3 first generations of CT through the introduction of digital imaging and flat panel detectors. In parallel, he participated as an expert in working groups elaborating IEC standards for Quality Control protocols, radiation protection in diagnostic X-ray equipment, X-ray equipment for radiography and radioscopy, X-ray equipment for interventional procedures, mammographic X-ray equipment, anti-scatter grids, DQE of digital x-ray imaging devices, and Radiation conditions for use in the determination of characteristics.