Sometimes, medical device companies do not handle a complaint correctly. Sometimes they do not follow an adequate design control process or misrepresent their device. Sometimes their packing is missing a compliant IFU. And then there are times when all of these things are happening at once. Where a medical device company is simply not operating … Read more
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
Controlling medical device monitoring and measuring equipment is an essential element of an ISO 13485 QMS. Monitoring and measuring equipment verifies that a medical device is safe to put on the market, so any issues with the equipment’s accuracy can put patients at risk. This article will provide a guide for understanding and implementing the … Read more
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
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
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