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

ISO 13485 Training Requirements: The Complete Guide

Do you want to create an effective training program that meets ISO 13485 training requirements? This article will cover all the ins and outs of the Human Resources section (6.2) of ISO 13485:2016, and provide a complete guide to creating a compliant training procedure. Training is one of the most important things for a company … Read more

FDA Warning Letter: Olympus Medical Systems (Part 2)

Welcome to this week’s installation of Warning Letter of the Week (WLOTW). This week, we will be continuing our series on a Warning Letter issued to Olympus Medical Systems (full Warning Letter). Last week, we discussed the first finding listed in the Warning Letter, which was related to not correctly handling NCR and complaint data … Read more

FDA Warning Letter: Olympus Medical Systems (Part 1)

Welcome to this week’s installation of Warning Letter of the Week (WLOTW). Each week we will review a different FDA Warning Letter to gather as much information as possible to avoid repeating those mistakes. The Warning Letters will range from recently posted letters to letters covering specific markets, and anything else we find interesting. If … Read more