Regulatory consulting service providing guidance on IEC 62304 medical device software life cycle processes, including CE marking, authorised representative designation, and compliance documentation. Supports medical device companies through regulatory requirements for diagnostic and therapeutic devi...
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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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