What is ISO 13485? The quality management standard for medical device manufacturing and its significance for PCBA production.
What is ISO 13485?
ISO 13485 is the international standard for quality management systems in medical device manufacturing.
ISO 13485 defines requirements for organizations developing and manufacturing medical devices. For EMS providers, this means complete batch traceability, validated manufacturing processes, documented training and systematic complaint management.
Process and Application
SMTEC is ISO 13485-certified and meets the stringent requirements for manufacturing medical device assemblies.
Frequently Asked Questions
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