Category: Servicing Legislation

Servicing Legislation


FDA to Host Public Workshop to Differentiate Between Servicing and Remanufacturing

In a bid to gather feedback for a future draft guidance, the U.S. FDA announced that it will hold a public workshop regarding the difference between servicing and remanufacturing. The workshop, titled “Medical Device Servicing and Remanufacturing Activities,” will take place at the Hilton Washington DC North Gaithersburg Hotel in Gaithersburg, Md., from December 10-11.

Servicing Legislation


The Great Wait: Will the FDA Increase Service Regulations or Not?

Since March 2015, the FDA has been collecting information and receiving factual and anecdotal comments concerning whether there is a public health and safety issue that warrants increased regulation and oversight of medical device companies and individuals. This issue culminated in October’s two-day workshop of presentations to the FDA, which biomedical expert Patrick Lynch details in the latest installment of The LynchPin.

Independent Service Organizations


Cultivating a Culture of Quality: Rick Lytle

In late November, Milwaukee-based Alpha Source acquired BC Technical, doubling the size of the former company. Here, Alpha Source CEO Rick Lytle discusses what the merger means for the healthcare industry and advises HTM professionals about what to look for when selecting a service provider.

Right to Repair


The Right to Repair: What’s a Biomed to Do?

In this article, 24x7 Magazine contributing writer Chris Hayhurst explores a very timely topic in the healthcare technology management (HTM) field: The right to repair. Here, Hayhurst talks to key industry leaders to get their insights about key steps HTM professionals can take in this battle. Don't miss out.