SigmaTech Nordic

SigmaTech Nordic provides regulatory, quality, and compliance services for medical devices, IVDs, medical software apps, and AI-enabled healthcare solutions.

Our expertise covers MDR & IVDR CE marking and certification, Quality Management Systems (ISO 13485), Risk Management (ISO 14971), Software Lifecycle Processes (EN 62304), and Cybersecurity (ISO 27001 & IEC 81001-5-1). We also support manufacturers in navigating the AI Act (EU) 2024/1689 and GDPR (EU) 2016/679 and the implications for medical devices and AI-based healthcare solutions.

We provide Quality Assurance (QA) interim regulatory support, helping companies strengthen their internal capabilities and maintain compliance throughout product development and market access.

For manufacturers based outside the EU, SigmaTech Nordic can act as an EU Authorized Representative (EU REP), supporting regulatory compliance and communication with European authorities.

Thus, we provide end-to-end regulatory support regulatory strategy and CE certification to QMS implementation and ongoing compliance to bring and maintain safe, compliant products on the EU market.