Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.

Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country to country.

The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.

Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done.

Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance.

I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No.

As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices.

In a highly regulated industry like medical technology, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing the correct result. The question is, which one should you use?

Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry.

For owners and operators in the agricultural and food-processing industries, Jan.