QA/QC

An industry expert said that a good manufacturing practice lawyer is the right person needed to review a challenging, sticky manufacturing investigation.

Getting medical device manufacturing designers, engineers, and production teams synchronized on a common product model improves product quality by reducing errors in production and increasing yield rates.

Manufacturers could see gains in efficiency, accessibility, and security when transitioning to a cloud-based data management platform.

The consequence of a stray label or an IFU could be the cause of a product recall, so manufacturers need to take precautions to avoid this as manual or weak processes could put the process in jeopardy.

What type of score will your company earn under FDA's Pre-Cert Program for Software as a Medical Device (SaMD)?

We hear plenty of advice on what practices will help improve manufacturing process and lower costs. But what should we stop doing to improve our manufacturing processes?