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

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 to get right if it wants to be successful. While many companies can train their … 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

Three Practical Ways to Show Effectiveness of Training for ISO 13485

Have you implemented an ISO 13485 compliant training system, but are still struggling to determine how to evaluate the effectiveness of training actions? You’re not alone. The effectiveness aspect of ISO 13485 clause 6.2 is something that causes the most difficulties when implementing a medical device QMS. You know your employees are trained and management … Read more

FDA Warning Letter: Forcemech

Welcome to the first 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 I find interesting. If … Read more

ISO 13485 Complaint Handling: The Definitive Guide

A medical device company’s complaint handling system is one of the most essential elements of its Quality Management System. A bad process will leave the company with an increased likelihood of audit findings, and present the company with possible legal and regulatory consequences. A good ISO 13485 complaint handling process can lead to increased customer … Read more