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Sigma Systems is a regulatory affairs and quality management consultancy for medical devices, offering MD-QMS/eMD-QMS development, regulatory documentation, software lifecycle regulatory support, audits, and training. They provide outsourced roles (Management Representative, QA/RA), ISMS and ISO 9001 consulting, and Authorized Representative services to support EU registrations and regulatory compliance, serving 250+ clients across 35+ countries. Based in Niš, Serbia, they claim global reach through projects, audits, trainings, and workshops worldwide.
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