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…
