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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FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff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FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.

By |2022-07-07T18:57:26+00:00July 7th, 2022|Uncategorized|Comments Off on 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FDA-2021-D-1158; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff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 [...]

By |2022-06-30T12:14:12+00:00June 30th, 2022|Uncategorized|Comments Off on FOR IMMEDIATE RELEASE

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 [...]

By |2022-06-30T12:13:42+00:00June 30th, 2022|Uncategorized|Comments Off on FOR IMMEDIATE RELEASE

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 [...]

By |2022-06-17T00:20:54+00:00June 17th, 2022|Uncategorized|Comments Off on FDA User Fee Legislation Advancing without Remanufacturing Add-ons

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 [...]

By |2022-06-08T16:47:58+00:00June 8th, 2022|Government, Healthcare|Comments Off on FDA to Amend Quality System Regulation

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 [...]

By |2022-03-24T14:08:38+00:00March 24th, 2022|Business, Government, Healthcare|Comments Off on OEM trade groups may be seeking to expand definition of ‘remanufacturing’ quickly and quietly

IAMERS 28th Annual Meeting

The IAMERS 28th Annual Meeting will be held in Charleston, SC from April 27th – 29th. PLEASE NOTE: room reservations at the host hotel to be made through IAMERS. Come early so you don’t miss the Wednesday morning (26th April) tour of Charleston. DOWNLOAD THE E-BROCHURE DOWNLOAD THE REGIStration Form [...]

By |2022-02-22T21:26:07+00:00February 22nd, 2022|Uncategorized|Comments Off on IAMERS 28th Annual Meeting

Considerations for effective healthcare vendor management in 2022

At the annual IAMERS educational meeting in Chicago last week, IAMERS took a deep dive on vendor management trends and best practices with two seasoned industry veterans. Intermountain Healthcare's director of clinical engineering, Michael Powers, and Crothall Technical Resources' vice president, Sheila O’Donnell, presented on 2022 best practices. The 90-minute discussion drilled down about the [...]

By |2021-12-09T17:50:53+00:00December 9th, 2021|Business, Conference, Healthcare|Comments Off on Considerations for effective healthcare vendor management in 2022
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