Medical Design and Outsourcing

Georgia state officials want more test results from Sterigenics before they will allow the company to reopen its medtech sterilization plant in Atlanta. In a letter dated Wednesday, the state Environmental Protection Division (EPD) told Sterigenics to test new emissions-control equipment that the company installed after voluntarily closing the plant Aug. 26, and to report…

What Is the EU MDR? In May 2017, the EU published the new European Union Medical Device Regulation (EU MDR). The new regulation replaces the MDD (Medical Device Directive) and went into force on May 25, 2017. Medical devices have three years to comply while in vitro diagnostics have five years. The reasons for the…

This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA Internal Medicine editor Dr. Rita…

Medtech companies have demanded increasingly complex geometries in medical tubing. Here’s a rundown of five manufacturing processes that could help them get there.  Dan Sanchez, Trelleborg Healthcare & Medical Here are several tubing processes that may be of interest to medical device designers: Geometric transition extrusion With geometric transition extrusion, tool components can be moved during…

Regulations at the FDA and in the European Union are in constant flux, and that’s not even mentioning Brexit. Here’s how one regulatory expert keeps ahead of the changes. The regulatory space for medical devices is always evolving. Manufacturers have to keep up not only with FDA regulations, but other countries’ rules ­ not to…