16th IAMERS European Meeting
Join us for the 16th IAMERS European Meeting. Amsterdam, 15th – 17th September 2021 Click here to download the brochure and learn more
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 [...]
FDA Service and Remanufacturing Draft Guidance: Key Takeaways
By Robert J. Kerwin On June 18, 2021, the FDA released its long-awaited draft guidance entitled Remanufacturing of Medical Devices.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 [...]
IAMERS Who’s Who
IAMERS is a trade association whose members are world-class providers of pre-owned medical imaging systems, parts and [...]
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 [...]
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 [...]
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 [...]