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|0 Comments

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|0 Comments

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

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

Biden’s Executive Order on Competition Offers Path Forward to ‘Repair Markets’

On July 9, 2021, President Biden issued a comprehensive executive order on competition. Entitled Promoting Competition In The American Economy, the order sets forth, in overview, measures designed for federal agencies to coordinate actions to address the problems of unfair competition, overconcentration, and economic consolidation. The executive order acknowledges the harmful anticompetitive effects of monopolies [...]

By |2021-07-22T11:09:01+00:00July 22nd, 2021|Reform, Regulatory, Uncategorized|Comments Off on Biden’s Executive Order on Competition Offers Path Forward to ‘Repair Markets’

FDA Service and Remanufacturing Draft Guidance: Key Takeaways

By Robert J. Kerwin On June 18, 2021, the FDA released its long-awaited draft guidance entitled Remanufacturing of Medical Devices. The 17-page document contains two appendices of examples and addresses both devices and software. The draft guidance, which does not apply to single-use devices and is not intended to include significant policy changes, aims to [...]

By |2021-07-16T23:14:09+00:00July 16th, 2021|Uncategorized|Comments Off on FDA Service and Remanufacturing Draft Guidance: Key Takeaways

IAMERS Who’s Who

IAMERS is a trade association whose members are world-class providers of pre-owned medical imaging systems, parts and service. We act collectively to positively impact changing government regulations, to defend against anti-competitive activities, and to provide an atmosphere for continuously advancing the knowledge of our members. Whether impacting government regulation, continuing education or monitoring anti-competitive activities, [...]

By |2021-09-08T13:08:06+00:00February 11th, 2021|Uncategorized|Comments Off on IAMERS Who’s Who

Reviewing some of the key considerations for cyber insurance

June 24, 2020 By Robert J. Kerwin  The 2020 global increase in malicious cyberactivity against companies has been well reported. As of March 30, 2020, the FBI's Internet Crime Complaint Center (IC3) reported it had received and reviewed more than 1,200 complaints related to COVID-19 scams.  In a previously published report, the global cyber education [...]

By |2020-06-30T17:02:10+00:00June 30th, 2020|Uncategorized|Comments Off on Reviewing some of the key considerations for cyber insurance

New IMDRF Cybersecurity Guidance: Crystal Ball on Regulator Expectations

June 4, 2020By Robert J. Kerwin In the wake of the enormous increase in cybersecurity incidents, medical device regulators world-wide have been engaged in the development of pre-market and post-market guidance outlining cybersecurity expectations. In March, the International Medical Device Regulators Forum (“IMDRF”) released the guidance, “Principles and Practices for Medical Device Cybersecurity”.It is the first IMDRF [...]

By |2020-06-06T09:12:08+00:00June 6th, 2020|Uncategorized|Comments Off on New IMDRF Cybersecurity Guidance: Crystal Ball on Regulator Expectations
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