Regulatory consulting service specializing in ISO 13485 certification and CE marking for medical devices. Supports diagnostic and therapeutic device manufacturers through compliance documentation, authorised representative services, and regulatory strategy across European markets. Fixed-price offeri...
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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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Medical device regulatory consulting services supporting manufacturers with CE marking, FDA 510(k) clearance, and UKCA certification. Provides technical documentation preparation, risk management, clinical evaluation, and audit support for compliance with EU MDR, EU IVDR, and UK regulatory requirements.
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ISO 13485 certification validates that medical device manufacturers have established and maintain quality management systems compliant with international standards. This certification demonstrates organizational capability to design, produce, and deliver safe and effective medical devices. Essential for regulatory approval and market access across global healthcare markets.
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ISO 13485 certification service for medical device manufacturers ensuring compliance with international quality management standards. BSI provides accredited certification and auditing to establish safety, efficacy, and regulatory acceptance of medical devices across global markets.
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