Posts categorized as“Regulatory”

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.

This is the second blog in series of three that cover our recent experience with FDA inspections 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!), while this one discusses inspection outcomes. The last blog will cover lessons learned.

What is adaptive design for clinical study and why is the Medical Device community so excited about it? An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity.

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 […]