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
Spoiler Alert: This article isn’t going to tell you how many SOPs to create. Instead, I want to provide a framework for thinking about SOPs and other documents, and what the benefits are to different approaches. Each company will handle this question differently, depending on the specific tools and shortcomings of that company. However, it’s … Read more
You’ve qualified your suppliers and purchased their products, but what should a company do once the products arrive? ISO 13485 section 7.4.3 is all about the verification of purchased products to ensure they meet the company’s and supplier’s specifications. What are the requirements for verification of purchased product? The variety in purchased product verification can … Read more
It’s the third day of an audit. While you’ve been enjoying the provided lunches and getting away from checking email, you’re no longer entertained by the auditors’ elaborate stories and anxiety that a haywire Teams message will appear on the screen you’re sharing. For the last hour, he’s been locked in on one form that … Read more
When it comes to Medical Device companies’ purchasing processes, managing suppliers 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. Supplier management is critical for medical device companies as the quality and safety of their devices is determined by the products and services coming in their door. Many medical device companies have difficulty with supplier management, and for good … 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