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 [...]

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 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 [...]

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 [...]

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. [...]

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.

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 [...]

Here are some of our members enjoying Madrid.Download

GE chairman and CEO Larry Culp said in light of its just-announced deal with Danaher, the IPO for its healthcare division may be delayed. Read more here.

Cuts of up to $112 million in Medicare ultrasound reimbursements have organizations like the American College of Radiology calling for radiologists to clarify the actual costs of purchasing and servicing ultrasound equipment. Read more here.