Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Elizabeth Orr

Washington, DC
Elizabeth Orr focuses on legal affairs affecting the medical device industry. Before joining Informa in September 2015, she spent three years spent reporting on all things device-related at FDANews. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner.  A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.
Set Alert for Articles By Elizabeth Orr

Latest From Elizabeth Orr

FDA Tracks Critical Device Supply During Puerto Rico Hurricane Recovery

Continuing recovery efforts in Puerto Rico have US FDA focused on life-sustaining devices or those only made on the island. Meanwhile, manufacturers including Baxter, Zimmer, J&J and Abbott report varying impacts from the storms.

Medical Device Puerto Rico

NuVasive, Alphatec At Odds Over Exec Job Change

NuVasive has sued a former executive and board member for breach of contract after his move to competitor Alphatec. The smaller company says the basis of the lawsuit is “fictional.”

Medical Device Legal Issues

Many Firms Use Old-Fashioned Complaint Handling Tactics, Survey Finds

A recent study by Sparta Systems revealed that more than four in 10 companies, including device-makers, still primarily handle customer complaints on paper, or via a decentralized system like Microsoft Excel or Access. Two quality assurance experts weigh in.

Quality Control Compliance

FDA Looks For Diverse CMMI 'Maturity' Pilot Enrollees; Device-Makers Expect Big Savings

The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.

Quality Control Compliance

Radiology Display Device 510(k)s Guidance Issued

US FDA's 14-page guidance, issued Oct. 2, outlines the agency’s recommendations for 510(k)s seeking clearance for the viewing units used in diagnostic radiology, finalizing a 2016 draft guidance.

Medical Device Diagnostic Imaging

Questions Answered On Device Submission Woes

Device-law attorney Jeffrey Gibbs answered caller questions during a Sept. 27 MassMedic webinar. Topics addressed include marketing, enforcement, and preparing for FDA meetings

Medical Device Legal Issues
See All