Today the FDA released its final guidance to provide the medical device industry clarity on the definition of "remanufacturing" for reusable devices needing maintenance or repair, a lingering point of ambiguity in an overarching discussion about right-to-repair. A draft of the guidance was initially released for comment and consideration back in 2021, at which time [...]
Last week, IAMERS (the International Association of Medical Equipment Remarketers and Servicers) celebrated its 31st birthday in Charleston at the IAMERS Annual Meeting. After IAMERS President Diana Upton welcomed the group, the Annual Meeting kicked off with a keynote presentation by Dr. Mike Bivins, president of Urology Centers of Alabama. Dr. Bivins offered some candid [...]
By Robert J. Kerwin While efforts in Washington D.C., and indeed nationwide, have sparked momentum toward widespread acceptance of the rights of device owners to choose who would repair the devices they own, recent approval by the European Parliament and the Council of the EU of the European Data Act may be a great leap [...]
We are excited to announce the release of the 2024 IAMERS Who's Who. Click here to learn more.
Dear Members, We’re looking forward to seeing you in the beautiful city of Charleston for the 31st Annual IAMERS meeting. Meeting Times Monday 29th April 6:30 pm – Reception & Dinner at The Charleston Place Tuesday 30th April 8:00 am – Breakfast 9:00 am – Business sessions (lunch included) 4:00 pm – Meeting adjourns for the [...]
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.
