Have you ever heard of Goodhart’s Law? Developed by British economist Charles Goodhart, the simple version is: “When a measure becomes a target, it ceases to be a good measure.” On its own, it’s a beneficial concept for Quality Management. For example, if you record the time it takes good, well-trained inspectors to measure a … Read more
When it comes to Medical Device companies’ purchasing processes, supplier management takes the bulk of the attention. This makes sense, as having a great supplier management system will make the other parts of the system run much smoother. That being said, Medical Device companies that want to conform to standards and regulations should still record … Read more
All medical devices start from somewhere, and that somewhere is usually supplied by an outside organization. For medical device companies, the quality and safety of their devices are essential, which means that they must guarantee that high-quality products and services are coming in their door. The first step in ensuring they are provided quality materials … Read more
While medical device companies can get caught up with processes and regulations, they are still businesses. And since they are businesses, they will have customers who purchase their products or services. In fact, ISO 13485 has an entire clause (7.2) dedicated to customer-related processes to ensure this aspect is incorporated into a company’s QMS. Like … Read more
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