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, [...]
Brexit agreement begins now: Are you ready?
By Robert J. Kerwin It was four years ago that Britain’s then-prime minister, David Cameron, set a referendum on the U.K.’s continued membership in the European Union. [...]
FDA adverse event reporting form to include question as to third-party service
By Robert J. Kerwin Medical device manufacturers, importers, distributors and user facilities have long been required to report deaths, serious injuries and malfunctions that have, may have [...]
First federal ‘right to repair’ legislation filed in US to help hospitals through pandemic
An opinion piece by Robert J. Kerwin Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed [...]
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 [...]
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 [...]
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 [...]
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 [...]
HSCC Legacy Medical Device Task Group Aims to Mitigate Cyber Threats
May 13, 2020 By Robert J. Kerwin This article is reprinted with permission of DOTmed HealthCare Business [...]