Our Fermoy, Ireland, facility is FDA registered and certified to ISO for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. […]
We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. […]
Identifies, plans, and organizes regulatory affairs for ensuring compliance with the FDA's Quality System Regulations, ISO 9000, ISO , JPAL as well as all international standards relevant to customer products for...