About

SigmaTech Nordic is your partner for regulatory compliance in Medical Devices and In Vitro Diagnostics. Our services ensure navigation through complex regulatory landscapes. From CE-marking to QMS implementation, Regulatory Strategy assessments to Gap analysis, our expertise encompasses every aspect of compliance.

Trust us for specialized services such as Software Life Cycle implementation (IEC 62304), Post-market surveillance, QA training (certified), and thorough Audits (internal and supplier).

Also, for our non-EU clients, we offer Authorised Representation services.