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|Comments Off on Draft Standard on Refurbishing Equipment Could Lead to Greater Manufacturer Control

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|Comments Off on AdvaMed and MITA exit collaboration with non-OEM service stakeholders

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|Comments Off on Implementation of the EU MDRs Delayed Until 26 May 2021

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|Comments Off on IAMERS Joins Healthcare Sector Coordinating Council Cybersecurity Working Group

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|Comments Off on Continued Advocacy

FTC needs to enforce pandemic moratorium on denying access to medical device service information

April 29, 2020 An editorial by Robert J. Kerwin Originally publish on DOTMed Health Care Business NewsWith a big tip of the hat to Captain Obvious, our hospitals and health delivery organizations are heroically dealing with a terrible pandemic the likes of which we have no real comparison for in our lifetime. As Healthcare Business News [...]

By |2020-05-12T13:28:39+00:00May 12th, 2020|Uncategorized|Comments Off on FTC needs to enforce pandemic moratorium on denying access to medical device service information

MITA’s remanufacturing white paper recalls ‘Groundhog Day’ movie: IAMERS

Read more here. “Nowhere in the white paper does MITA provide support for its claim of an increased "risk to the public health." As MITA once acknowledged in its previous submission to the FDA it is impossible to provide a statistically valid analysis of the extent of problems.”

By |2019-02-18T11:55:34+00:00February 18th, 2019|Uncategorized|Comments Off on MITA’s remanufacturing white paper recalls ‘Groundhog Day’ movie: IAMERS
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