Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) ...
Tags: QSR, certification
Medical device contract manufacturer Norman Noble, Inc. today announced Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-Free), an exclusive, athermal laser machining process that represents an advancement of several ...
While many media outlets are headlining the top-line numbers in today's FDA report that show that the number of medical device recalls have nearly doubled in the last 10 years, a look underneath the surface reveals that the rate of recalls ...
FMI Inc. Chicago-based medical silicone component manufacturer FMI today announced a new program aimed at helping medical device companies get new projects to market faster. Chicago-based medical silicone component manufacturer FMI today ...
Tags: silicone component, medical device, Health
Just when Hospira Inc.'s Rocky Mount, NC–manufacturing facility was starting to think it could breathe a little easier, FDA delivered another Warning Letter. The Lake Forest, IL-–based manufacturer of pharmaceuticals, other ...
Tags: medical device, Health, Medicine
The world's top 40 medical device companies overall have enjoyed a slight gain in stock price so far this year. But there are exceptions to the rule as well, with reasons ranging from Getinge AB's quality control issues to Terumo Corp.'s ...
Tags: Medical Device, Health, Medicine
David Schnur Associates (DSA) announced today the conclusion of a multi-year agreement to represent Vention Medical’s full Advanced Component portfolio in the State of Israel. This portfolio includes balloons and balloon catheters, ...
Tags: Vention Medical, medical device, specialized component technologies
Redwood City, CA–based EarLens, which has developed a light-based method for delivering sound to the ear, has raised more than $36 million from 22 investors, according to a recent SEC regulatory filing. Company officials could not ...
Secant Medical, Inc. has announced its newly branded website at www.secantmedical.com.The redesigned site serves as a source for new and existing clients to learn more about the company's advanced biomaterials and biomedical textile ...
Tags: medical, Biomaterials, Biomedical
Add AT&T to the list of high tech companies seeking to increase their visibility in the medical device industry: The Dallas–based telecommunications giant has appointed digital health notable Eric Topol, MD, as its new chief medical ...
Tags: health
Tegra Medical Tegra Medical announces the appointment of Mr.J.Mark King as its new Chief Executive Officer. BOSTON,MA,January 15,2014-Tegra Medical is very pleased to announce the appointment of Mr.J.Mark King as its new Chief Executive ...
Tags: Tegra, Tegra Medical, Health care
Global standards organisation GS1 has received accreditation by the US Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDI). Global GS1 Standards meet the government’s criteria for UDI and will ...
Tags: FDA Accreditation, GS1
The University of Minnesota is looking to recruit students for its master's degree program in medical device innovation. The engineering-focused curriculum is designed to prepare students for careers in the medical device industry, which ...
For the medtech industry, 2014 is unlikely to be a year full of surprises as companies grapple with a health care market wary of big-ticket procedures and items. The largest gains will likely involve digital health and other technologies ...
Creganna-Tactx Medical has announced today that Robert B. Hance will join the company as Chief Executive Officer in September 2013, taking over the role from Helen Ryan who has held the position for the last eight years. Robert ...
Tags: medicine, Creganna-Tactx Medical