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 13485:2016 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