CE marking certification and regulatory consulting service for medical devices. Provides compliance support, authorised representative designation, and regulatory pathway guidance for diagnostic and therapeutic devices across European markets. Supports ISO 13485 implementation and pre-market certifi...
Manufactured by
SigmaTech Nordic
Frederiksberg C, Denmark
SigmaTech Nordic offers services in certification of medical applications and devices (CE marking), implementation and training related to Quality Management (ISO 13485), Risk Management (ISO 14971), Software Life-Cycle processes (EN 62304), Cybersecurity (ISO 27001 EN 81001-5-1), AI ACT (EU) 2024/1689, Quality Assurance (QA) outplacement, and acting as an Authorized Representative (EU REP) for non-EU manufacturers.
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Regulatory consulting services supporting medical device and IVD manufacturers through CE marking, FDA 510(k) clearance, and UKCA certification processes. Assists with technical documentation, clinical evaluation, risk management, and conformity assessment to meet EU MDR, EU IVDR, and UK regulatory requirements.
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