Medical Device Regulations
The Cogmedix team is a fully trained and compliant cGMP manufacturing organization.
The Cogmedix team is a fully trained and compliant cGMP manufacturing organization. With superior processes and equipment to expedite and simplify the delivery of state-of-the-art solutions, Cogmedix has become a valued partner to leading medical device companies. What can Cogmedix do for you?
Medical Device Certifications & Capabilities
- Class I, Class II and Class III Medical Device Manufacturing
- 21 CFR Part 820 Compliant Contract Manufacturing Services and Facility
- ISO 13485:2003 certified by TÜV SÜD
- Registered Laser Facility Compliant with the Requirements of American National Standards Institute Z136 Guidelines and 105 CMR 121.000
- Automated surface mount and through hole PCB assembly in our J-STD-001 certified, 2-shift stand alone facility; 0201, 1005 capabilities, BGA, micro-BGA
- Complete PCBA testing services including ICT, X-Ray, AOI, and functional test
- In house soldering and crimping trained personnel to IPC-A-610 & IPC/WHMA-A-620 standards
- Degreed engineers on staff including Mechanical, Electrical, and Physics
- On staff regulatory expert with nearly 20 years in FDA regulated environments including pharma and medical device manufacturing