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FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff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FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and [...]
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 [...]
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 [...]
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 [...]
IAMERS 16th European Meeting
We are excited to announce the IAMERS 16th Annual European Meeting 14 – 16 September 2022 Sofitel [...]
FDA to Amend Quality System Regulation
In its continued efforts to harmonize with international regulatory authorities, the U.S. Food & Drug Administration has [...]
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 [...]
2022 IAMERS Who’s Who
We are excited to announce the publication of the latest IAMERS Who's Who. Click here to read [...]
IAMERS 28th Annual Meeting
The IAMERS 28th Annual Meeting will be held in Charleston, SC from April 27th – 29th. [...]