On Thursday, December 4 at BIOMEDevice San Jose, Thor Rollins, in vivo biocompatibility section leader at Nelson Laboratories Inc. (Salt Lake City, UT), will speak on "Materials Selection and Sampling Techniques for Biocompatibility (ISO 10993)."...
![Alpha Medical Cited by FDA on Balloon Catheter Quality]()
A nine-day FDA inspection at Alpha Medical Instruments in Mission Viejo, CA, in August found Quality System Regulation violations in the firm’s manufacturing of angiographic balloon catheters.
![FDA Finds QSR Breaches at South Korea’s Infopia]()
An FDA inspection at Infopia in Anyang-si, South Korea, has found Quality System Regulation violations in the firm’s manufacturing of several glucose and lipid devices.
Why does something so simple become so difficult?
To compete, grow, and innovate, manufacturers should adopt a cloud-based enterprise resource planning system that integrates quality management functionality.
The Blue Earth, MN, firm's violations include failing to establish adequate procedures for acceptance of in-process product and failing to establish adequate procedures for corrective and preventive action.
There's been a change afoot in the medical device industry in the way companies test for biocompatibility--with a shift away from animal tests toward chemical characterization tests in the laboratory, according to Thor Rollins, a biocompatibility...
The violations were found violations in the firm’s work as a specification developer of the Syringe Key and ER-SHOT devices.
Patrick Kahl of Abbott Vascular explains how to properly document a quality system exception.
