Alva Prototypes is ISO 13485 certified and FDA registered. We inspect parts in our Pottstown, PA shop and ship them with an inspection report.
ISO 13485
We maintain a quality management system certified to ISO 13485, the quality management standard for medical device manufacturing.
FDA registered
Alva Prototypes is registered with the U.S. Food and Drug Administration.
In-house inspection and inspection reports
Parts are inspected in-house before they ship, and each shipment goes out with an inspection report.