FDA Approved Assemblies
Rapid advances in life sciences are driving the growing demand for specialized equipment from certified design centers and factories. The ISO 13485 certification is a requirement for factories that manufacture FDA approved assemblies. This stringent quality certification requires detailed design and manufacturing processes that provide customers the assurance of highly uniform manufacturing processes. Our new product introduction (NPI) engineering teams can provide full optical, mechanical and electrical system support from design to volume manufacturing of FDA approved biomedical assemblies.