The DITTA Contribution to IMDRF Stakeholder Forum on open work items can be found here.
WASHINGTON, DC – On September 15, DITTA, the global voice of the medical imaging and radiation therapy industry, organized a day-long seminar to discuss the standards “lifecycle” from idea to implementation, including best practices, the future of international standards, and their impact on patient safety and innovation. This seminar was day 1 of the 6th IMDRF week.
Over 100 attendees from around the world came to learn from the speakers from the USA, Canada, the EU, Latin America, and Asia. Industry, Standardization Organisations, governments, healthcare professionals and other important stakeholders provided their perspectives on how standards affect their work every day. They shared best practices and openly discussed ways to increase patient safety while making smart use of regulatory resources through careful reliance on consensus-driven and science-based international standards.
MITA Executive Director and Co-Chair of DITTA Gail Rodriguez, characterized the day as “a great platform for discussion of how standards are used in regulations around the world, and how industry, regulators, and healthcare community including patients all benefit from using standards in medical device regulations. Participants agreed there is a need for more discussion on the applications for standards in medical device regulations, and identifying standards which when used effectively can contribute to safety of the equipment, enhancing quality and driving cost efficiency”.
COCIR Secretary General and Chair of DITTA Nicole Denjoy thanked the speakers and praised the outcomes of the day, saying “DITTA is very pleased with the caliber of speakers and presentations and turnout of attendees. It remains important to get support of regulators to drive regulatory convergence with the help of international standards. National deviations should be avoided to optimally benefit from international standards. This way we can also prevent from creating trade barriers.”
DITTA International Standards: The Value and Mechanics of Medical Device Standards in the 21st Century
A seminar to discuss the standards “lifecycle” from idea to implementation, including best practices, the future of international standards, and their impact on patient safety and innovation.
Monday, September 15, 2014
8:30 a.m. – 5:00 p.m.
Agenda available here .
Presentations from the event