The FDA is required to inspect Class II and III medical device companies every two years. What happens if the FDA observes something that violates good manufacturing practices during the inspection? This is where an FDA Form 483 comes in. An FDA Form 483 is a documented notice of regulatory violations observed during an FDA … Read more
A Quality Policy is the highest-level document for a medical device company. It is the star on the top of the Christmas tree, and the guiding light for a medical device QMS. So how does a company make one? If you are wondering how to make an excellent Quality Policy for your company, you’re in … Read more
Welcome to this week’s edition of Warning Letter of the Week (WLOTW)! We will be explaining an FDA Warning Letter given to Abbott Point of Care (POC) related to their product “i-STAT cTnI Test”. The warning letter covers issues with design control and 510(k) clearance while including one of the funniest lines I have read … Read more
While many aspects of FDA and ISO 13485 quality system requirements can be found in other industries, Device Master Records (DMR) are something that is unique to medical devices. This can lead to confusion about what a DMR is, what is required, and how a DMR can best be integrated into a medical device quality … Read more
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
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
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 hundreds of 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 … 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