Posts categorized as“Quality”

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 […]

Due North InnovationSketch to Launch Process I described the Sketch to Launch process that Brenda Edin and I use at Due North Innovation to provide commercialization services to the medical industry at the recent Medical Device Commercialization Playbook event in Vancouver BC.  The following is a transcript of my talk at the event.