Understanding Medical Device Change Control (ISO 13485)

Change is essential and necessary for any organization, especially medical device manufacturers. Organizations need to be constantly aware of changes to materials, suppliers, processes, specifications, and other items related to their products. Not only are medical device companies required to be mindful of changes, but they must implement change control to maintain the function of … Read more

Passing the ASQ CSSGB Exam: Tips and Tricks

I recently became an ASQ Certified Six Sigma Green Belt (CSSGB) and wanted to go over my experience with studying and passing the exam. This article will cover the process for applying, studying, and taking the exam, and will provide all the study material I used to pass the exam on the first try. As … Read more

Document Control for ISO 13485 Explained

It’s impossible to have a well-running ISO 13485 QMS without a good document control procedure. Not only will it leave your QMS open to undesired changes and gaps, but it can also lead to confusion and costly mistakes. Document control is also the area of a QMS where it is easiest to get findings during … Read more

Mastery of Management Review for ISO 13485

Management’s commitment to the Quality Management System is one of the key principles of ISO 13485. One of the ways management’s commitment is demonstrated is through management reviews (ISO Clause 5.6). While management review is frequently seen as a box to check to meet ISO 13485 requirements, if properly executed, it can be a powerful … Read more

FDA Warning Letter: Olympus Medical Systems (Part 3)

Welcome to this week’s installation of Warning Letter of the Week (WLOTW). This week, we will be the last article in our series on a Warning Letter issued to Olympus Medical Systems (full Warning Letter). So far, we’ve dived into issues relating to Olympus Medical not properly handling data, not performing re-validation on sterilization processes, … Read more