In fast-moving manufacturing environments, getting it right the first time is critical, which is where First-pass yield (FPY) comes into play. It tells you how well your process is running, how reliable your product is, and how efficiently your line is…
How to Design a Flexible Leak Testing Process for Rapid Device Innovation
Innovation in medical device development is moving faster than ever. As timelines shorten and product iterations accelerate, quality processes must keep pace, especially when it comes to leak testing. Whether you’re launching a next-gen drug package or refining an existing assembly,…
Non-Destructive Leak Testing for Medical Devices: Myths, Methods, and Must-Haves
For manufacturers of sterile medical devices, leak testing plays a critical role in maintaining patient safety, meeting regulatory requirements, and delivering consistent product quality. But despite its importance, leak testing is often misunderstood, misapplied, or underestimated, especially when it comes to…