Recently Michelle Fields, W7 Global (USA) asked Christian Frandsen, Agito Medical (Denmark) the following question. Christian is a logistics expert – worldwide. ––––––––– Christian, Hello! I sat in on your talk about Logistics at the IAMERS meeting in Greece. I have a question I am not sure if you can answer or direct me to [...]
ECR – Vienna 28 Feb – 3 Mar 2024 IAMERS Member Reception Thursday 29th Feb 2024 7pm – 10pm Palais Hansen Kempinski __ IAMERS 31st Annual Meeting 29th Apr – 1st May 2024 The Charleston Place Charleston, SC __ IAMERS 18th Annual European Meeting 18th & 19th Sept 2024 Pulitzer Hotel Amsterdam, NL __ [...]
On October 19, 2023, the U.S. Copyright Office published notice in the Federal Register that it was recommending to the Librarian of Congress certain Petitions for Renewal of the Exemptions that were granted in 2021 from the Digital Millennium Copyright Act (“DMCA”) prohibition against circumvention of technological measures that control access to copyrighted work. The [...]
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FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.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 [...]
In its continued efforts to harmonize with international regulatory authorities, the U.S. Food & Drug Administration has an nounced its intention to amend the current good manufacturing practice requirements of the FDA quality system regulation, 21 C.F.R 820 et seq. to align more closely with the international consensus standard for devices, ISO 13485. This is [...]
An op-ed by Robert J. Kerwin As the 2021 Federal Trade Commission (FTC) report to Congress on repair restrictions acknowledged, some medical equipment manufacturers are limiting the availability of diagnostic software and firmware necessary to make repairs. That situation may soon worsen, if legislation proposed by a manufacturer trade association is filed and approved. This [...]
