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
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
Are you struggling to ensure your training program meets ISO 13485 training requirements? You’ve come to the right place. This article will cover all of 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 … Read more
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 Letters are an immediate call to action for an FDA-regulated company. Then can end up costing a company thousands of dollars, and result in a negative reputation with customers and other companies. If the actions listed in the Warning Letter are not diligently corrected, they can also lead to even greater fines and … Read more
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
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
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
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