C-MAC Canada Captures 13485 Certification
Sherbrooke, Quebec, Canada -- C-MAC MicroTechnology’s North American hybrid circuit manufacturing facility, C-MAC Microcircuits, ULC, has achieved ISO 13485 Certification for medical devices.
ISO 13485 is a medical device quality systems standard that supplements ISO 9001. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention and regulatory actions, which are more critical for the medical device industry.
"C-MAC activity in the medical market clearly required the ISO 13485 certification. The certification of a quality management system specifically for medical devices proves advantageous, and in many cases essential, for C-MAC to continue to grow our business in the global market," said John Tran, North America sales manager, C-MAC MicroSystems Solutions Division.
C-MAC Microcircuits produces a wide range of functional modules for use in the telecommunication, industrial, medical, military and automotive systems. The technology encompasses multiplayer thick-film interconnect substrates, surface-mount hybrid circuits along with direct-attach flip-chip and chip & wire assemblies.
