Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

Maintaining a healthy quality system and complying with the Food and Drug Administration’s expectations has never been more important for manufacturers making medical devices bound for the US market.

FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

Injection molding machine maker Engel reports that it will debut a digital process validation tool for medical technology applications at K 2025 in Düsseldorf, Germany. The custom product combines ...

Medical innovation is exciting. It’s thrilling to think a new therapy, device or product can improve the quality of or save ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Key Takeaways Prototyping accelerates the medical device development journey, enabling rapid iterations based on user ...