Manufacturing Regulations and Certifications

The Cogmedix team is a fully trained and compliant cGMPmanufacturing organization.

Trained 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

Coghlin Companies, with its two wholly owned subsidiaries—Columbia Tech and Cogmedix has been certified by:

Coghlin Companies Certifications