by Jeremy Linden, Asimily Cyberattacks against healthcare providers are increasing, with a rapid increase seen during the pandemic and a further rise of 94% in 2022. As more of these devices become connected to the network, attacks that may have once been costly could now turn deadly. Independent service organizations (ISOs) have an important role [...]
Click here to read our letter regarding Docket No. FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.
IAMERS is pleased to announce the appointment of Mike Powers, MBA, AAMIF, CDP, Clinical Engineering Director at Intermountain Healthcare, to the IAMERS Board of Directors. IAMERS President Diana Upton noted: “Mike is a healthcare industry leader. He brings a wealth of experience and team building to the IAMERS Board with his clinical engineering experience at Intermountain Health [...]
IAMERS, an international diagnostic imaging trade association, is pleased to announce that Richardson Electronics Vice President Jerald Olsen who joined the IAMERS Board in January 2021, will become Chairman of Marketing. IAMERS President Diana Upton applauded Jerald’s decision to join the Board: “Jerald is a proven leader in our industry. His unique contributions to Richardson and prior [...]
We have been hearing, for some time, rumors that powerful medical device manufacturers’ trade organizations were going to push Congress to tack onto the FDA User Fee Legislation new definitions of remanufacturing, which would redefine "remanufacturing" in a way likely to impact medical device servicing in a substantial way. All early signs pointed to this [...]
We are excited to announce the publication of the latest IAMERS Who's Who. Click here to read the latest issue.
On July 9, 2021, President Biden issued a comprehensive executive order on competition. Entitled Promoting Competition In The American Economy, the order sets forth, in overview, measures designed for federal agencies to coordinate actions to address the problems of unfair competition, overconcentration, and economic consolidation. The executive order acknowledges the harmful anticompetitive effects of monopolies [...]
By Robert J. Kerwin On June 18, 2021, the FDA released its long-awaited draft guidance entitled Remanufacturing of Medical Devices. The 17-page document contains two appendices of examples and addresses both devices and software. The draft guidance, which does not apply to single-use devices and is not intended to include significant policy changes, aims to [...]
IAMERS is a trade association whose members are world-class providers of pre-owned medical imaging systems, parts and service. We act collectively to positively impact changing government regulations, to defend against anti-competitive activities, and to provide an atmosphere for continuously advancing the knowledge of our members. Whether impacting government regulation, continuing education or monitoring anti-competitive activities, [...]
June 24, 2020 By Robert J. Kerwin The 2020 global increase in malicious cyberactivity against companies has been well reported. As of March 30, 2020, the FBI's Internet Crime Complaint Center (IC3) reported it had received and reviewed more than 1,200 complaints related to COVID-19 scams. In a previously published report, the global cyber education [...]
