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|0 Comments

FDA Service and Remanufacturing Draft Guidance: Key Takeaways

By Robert J. Kerwin On June 18, 2021, the FDA released its long-awaited draft guidance entitled Remanufacturing of Medical Devices.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 The draft guidance, which does not apply to single-use devices and is not intended to include significant policy changes, aims to [...]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|0 Comments

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|0 Comments

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|0 Comments

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|0 Comments

Draft Standard on Refurbishing Equipment Could Lead to Greater Manufacturer Control

May 27, 2020 By Robert J. Kerwin  With the gradual reopening nationwide of the economy, we are understandably focused on getting back to business, while ensuring the health and safety of our families. Raising a discussion of new ‘refurbishing standards’ for certain non-imaging medical equipment may provoke the question: how could this be relevant to [...]

By |2020-06-03T21:17:58+00:00June 3rd, 2020|Uncategorized|0 Comments

AdvaMed and MITA exit collaboration with non-OEM service stakeholders

by Gus Iversen, Editor in Chief DOTmed In a setback for improved cooperation between different medical equipment service stakeholders, two of the leading manufacturer trade groups, the Medical Imaging & Technology Alliance (MITA) and AdvaMed, have announced they will no longer be participating with in-house and independent service organizations in FDA-recommended Medical Device Servicing [...]

By |2020-10-02T14:52:18+00:00May 21st, 2020|Uncategorized|0 Comments

Implementation of the EU MDRs Delayed Until 26 May 2021

IAMERS continues its role, albeit virtually, as an official observer to the European Commission Medical Device Coordination Group. IAMERS has been participating in the MDCG Subgroup on the MDR regulations on Post Market Surveillance and Vigilance. Under these regulations, manufacturers will be furnishing to member country regulators no less than annually reports on the safety [...]

By |2020-05-12T17:16:23+00:00May 12th, 2020|Uncategorized|0 Comments

IAMERS Joins Healthcare Sector Coordinating Council Cybersecurity Working Group

IAMERS has joined on behalf of its members the Healthcare Sector Coordinating Council. The HSCC is a private-sector organized and managed council created to establish a process to coordinate improvements to the security of critical infrastructure. The U.S. Department of Homeland Security is required to engage and consider the advice of the Sector Coordinating Councils. [...]

By |2020-05-12T16:07:50+00:00May 12th, 2020|Uncategorized|0 Comments

Continued Advocacy

As many of you know we are continuing our advocacy (albeit virtually) with the Congress, EU and others. We wanted to bring to your attention, IAMERS latest efforts to advocate for greater access to service access information. Read more about our efforts here.

By |2020-05-12T13:32:19+00:00May 12th, 2020|Uncategorized|0 Comments
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