The industry leader in the development and production of implantable medical devices

Shifting to automated data analysis for process qualification activities can improve the effort for manufacturers and their customers in several ways.

Lowell’s manufacturing team needed to start making a customer’s part on a new machine. The newer mill/turn machine was automated and would save a lot of machining time versus the original milling machine, but it required reprogramming the part.

First article inspection (FAI) is a necessary step to ensure a manufacturing process will create a medical device that works as designed and meets requirements. It is a near-to-100-percent inspection of the first part that comes off a machine. The data and measurements gathered from FAI become part of the medical device file, which is required for FDA submissions and ISO 13485.

The FAI also builds confidence in the manufacturing process. Once it is submitted and approved, it’s assumed the same process will be in place for every part produced after that.

From a contract manufacturer’s perspective, a smooth FAI is important to its OEM customer’s satisfaction…

Metrology matching is a process that aligns two separate inspection systems—typically your system and a supplier’s—to ensure consistent results. The article written by Lowell…