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 or would be likely to cause or contribute to a death or serious injury. The FDA regulation pertaining to "user facilities" provides that reports should be filed on [...]

By |2020-10-02T12:49:18+00:00October 2nd, 2020|Government, Healthcare|0 Comments

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 Representatives the first federal right to repair legislation. “There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit [...]

By |2020-08-10T16:14:06+00:00August 10th, 2020|Government, Healthcare|0 Comments

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 News and can be read online in its original format at: https://www.dotmed.com/news/story/51199  In April, the FBI reported a global increase in malicious cyberactivity targeting U.S. Healthcare providers, noting that the cyberactivity was exploiting fear derived from the COVID-19 [...]

By |2020-05-14T16:45:54+00:00May 14th, 2020|Government, Healthcare|0 Comments

IAMERS CONTINUES TO ADVOCATE AS THE FDA SERVICING DEBATE RAGES ON DESPITE THE FDA REPORT RECOMMENDING NO NEW REGULATIONS

With rumors of a possible renewed push for Congressional legislation, IAMERS president Diana Upton and general counsel Robert Kerwin attended the AAMI Annual Meeting during the first week of June 2018. Their attendance is  part of IAMERS’ efforts to reduce the fear-mongering and  to get out the message of independent servicers for safe patient oriented [...]

By |2018-06-08T12:21:42+00:00June 8th, 2018|Government, Healthcare|0 Comments

MITA Continues To Omit In Its Proposed Servicing Standard

MITA continues to omit in its proposed Servicing Standard device manufacturer responsibility to provide appropriate documentation for technical descriptions, instructions for use and preventive and corrective maintenance and repair procedures, despite ANSI/AAMI EQ56: 2013. IAMERS after receiving a copy of the latest version of MITA's servicing standard, notified MITA that the Standard continues to impose [...]

By |2017-06-06T19:52:53+00:00June 6th, 2017|Business, Government, Healthcare|0 Comments

IAMERS Counsel Testifies Before Congress in Opposition to the Servicing Bill

Provided below is the link to the hearing held before the House Energy and Commerce Subcommittee on Health on 5/2/2017. The testimony of our general counsel Robert Kerwin and the questions placed by U.S. Congressional members to IAMERS and to MITA are important to our members. To see more about the hearing. Click here.

By |2017-05-02T20:58:01+00:00May 2nd, 2017|Government, Healthcare, Regulatory|0 Comments
Go to Top