IAMERS Annual Meeting
We are excited to announce the IAMERS Annual Meeting 1st – 3rd May 2023 Charleston, SC Click here for more info.
IAMERS’ 2023 ECR Reception & Dinner
We are excited to announce the IAMERS’ 2023 ECR Reception & Dinner Thursday, 2nd March Palais Hansen Kempinski Schottenring 24 – Vienna Click here for more info.
IAMERS at the RSNA
IAMERS annual RSNA member meeting and reception is on Monday November 28th at: The Ivy Room 12 East Ohio Street Member meeting @ 4:30pm - Our topic this year: A Few Things To Keep In Mind When Working With Your HDO on Cybersecurity Matters and Building Your Own Cybersecurity System – panel discussion. IAMERS members Sheila [...]
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FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff
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FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.
FOR IMMEDIATE RELEASE
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 [...]
FOR IMMEDIATE RELEASE
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 [...]
FDA User Fee Legislation Advancing without Remanufacturing Add-ons
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 [...]
IAMERS 16th European Meeting
We are excited to announce the IAMERS 16th Annual European Meeting 14 – 16 September 2022 Sofitel Grand Ile Strasbourg, France Click here to download the registration form.
FDA to Amend Quality System Regulation
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 [...]
OEM trade groups may be seeking to expand definition of ‘remanufacturing’ quickly and quietly
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 [...]