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 today in the U.S. Senate and the U.S. House of [...]
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 [...]
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 [...]
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 [...]
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 [...]