Quality Assurance
May 26, 2017
You know an FDA audit can happen at any time, but would you really be prepared if it happened today? Isabelle Noblanc FDA in December posted the most recent...
Jan 05, 2017
Learn how to use risk management tools and techniques to streamline medical device and diagnostic product development. Claudia Campbell-Matland, PMP The...
Mar 11, 2016
Three ways to demonstrate management oversight within your QMS. David Amor Over the past decade, FDA Quality Management System (QMS) deficiency findings in...
Nov 04, 2015
The 2015 revision of the ISO 9001 quality standard contains fundamental changes to the structure and contents of the standard and offers a preview of...
Oct 15, 2015
A quality system can be a big help or a big headache. Here are tips on how to put the right quality system in place. Katherine Cox For startup executives,...
May 28, 2015
An expert illustrates why test method validation is important in the real world. José Ignacio Mora Tom was ready to send the multi-cavity fixtures. I...
May 27, 2015
You know you need a validation master plan, but what should it include and what separates a strong validation master plan from an ineffective one? Marie...
Mar 30, 2015
Marie Thibault Spending on quality functions at medical device companies has increased over the past three years, according to the results of a recent...
Nov 04, 2014
By Jim Dickinson A nine-day FDA inspection at Alpha Medical Instruments in Mission Viejo, CA, in August found Quality System Regulation violations in the firm...
Nov 04, 2014
By Jim Dickinson An FDA inspection at Infopia in Anyang-si, South Korea, has found Quality System Regulation violations in the firm’s manufacturing of...