Founded in 1993 as an injection molding and electronics business, DEM Manufacturing now designs, engineers, and builds rugged electro-mechanical products entirely in the U.S. Its vertically integrated operation takes complex products from concept through production, with a particular history in military and law-enforcement communications and a newer medical-device division launched after its 2024 acquisition of Virtec Medical. DEM’s compliance-driven work includes ISO 9001:2015 and ISO 13485:2016 certification, ITAR registration, and FDA Class II medical-device registration.
ISO 9001:2015 - Quality Management
certification
ISO 13485:2016 - Medical Devices
certification
ITAR Registration (M47849)
registration
IPC/WHMA-A-620
certification
FDA Class II Medical Device Manufacturer Registration
registration
REACH Compliance
compliance_program
RoHS Compliance
compliance_program
Cybersecurity Maturity Model Certification (CMMC)
certification