Gap Analysis service identifies regulatory compliance gaps for medical device manufacturers pursuing CE marking and regulatory approval. This service evaluates current practices against ISO 13485 standards and applicable medical device regulations, supporting diagnostic and therapeutic device compan...
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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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Regulatory compliance consulting service for medical device manufacturers seeking CE marking, FDA 510(k) clearance, and UKCA certification. Supports conformity assessment, technical documentation preparation, risk management, and audit support across EU MDR, EU IVDR, and UK MHRA requirements.
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