Posts categorized as“Quality”

From a regulatory standpoint the differences between IEC 62366:2007 and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation that the whole process has been streamlined, using more familiar language and on the whole a more usable standard. Probably a good thing […]

Our content reflects topics that interest and engage StarFish employees.  We encourage everyone to write, participate in videos, make public presentations and help our clients (current and future) and colleagues (current and future) learn about us and our work. Every month we get together over a lunch to see what got read, clicked, liked and […]

This is the third blog in series of three that cover our recent experience with FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing. The first blog outlined our inspection preparation strategies (very different for each one!), the second discussed inspection outcomes, and this blog will cover lessons learned.

With the March 1, 2016 release of ISO 13485:2016, medical device developers and manufacturers have been given a three year grace period to implement changes from the previous 2003 version. During those three years both the 2016 and 2003 versions will be valid to operate under; however after the three year grace period, compliance with […]

What do EMC testing, changing from Alarp to AFAP, medical device colors and the pros and cons of two popular ultrasound signal processing techniques have in common?  If you guessed they were among the Top 10 most read medical device blogs of 2015, you’re probably an engineer, a QA/RA professional, or subscribe to  StarFish Medical […]