C-MAC Sherbrooke facility achieves
ISO 13485 certification
C-MAC MicroTechnology has achieved ISO 13485 certification of its North American hybrid circuit manufacturing facility, located in Sherbrooke (Quebec) Canada. The announcement adds to the ISO 13485 capability already achieved by C-MAC’s manufacturing facility in Great Yarmouth, UK.
ISO 13485 is a standard specific to medical device quality systems that supplements the ISO 9001 standard. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are critical for the medical electronics device industry.
“C-MAC activity in the medical electronics 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 us 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, ULC, (Sherbrooke) produces a wide range of functional modules for use in telecommunication, High-reliablity Industrial, medical electronics, military and automotive systems. Its advanced technology encompasses multilayer thick-film interconnect substrates, surface-mount hybrid circuits along with direct-attach flip-chip and chip-and-wire assemblies. The hybrid facility is approved to the latest ISO and TS requirements and is able to satisfy even the most stringent requirements of its customers.
July 2005
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