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Nationwide hosts IAMERS forum on QMS in advance of FDA report

August 16, 2017
HTM Parts And Service

The afternoon question and answer program was moderated by AAMI Vice President of Emerging Technologies and Health IT Joe Lewelling. While no formal poll was undertaken of those in attendance, it was observed that QMS is necessary and that QMS was enhanced with manufacturer cooperation. Steve Grimes, representing ACCE, spoke of his organization’s commitment to working with any stakeholders that are committed to improving the quality and safety of medical device systems. “We are very active in service and security standards, and have been working to ensure greater collaboration between the medical device and information technology communities in a number of areas, including interoperability and cybersecurity.”

Tim Martin of Radon Medical noted: “we work in rural areas, and hospitals depend on us. We are concerned about safety and traceability. The hospital is always the boss and we try very hard each day to meet their expectations.”

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A productive exchange of information did indeed happen throughout the forum, as promised by IAMERS President Diana Upton. The post-meeting comment of Ms. Bittleman of the FDA nicely sums up the general feeling of participants: “it was great to meet with people passionate about their work.”

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