Authorized Representative service for medical device companies navigating CE marking and regulatory compliance across Europe. Supports ISO 13485 certification and market authorization for diagnostic and therapeutic devices.
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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Maven Profcon Services LLP · India
Regulatory consulting service supporting medical device manufacturers with EU MDR, US FDA 510(k), and UKCA certification compliance. Provides technical documentation preparation, conformity assessment, and audit support to streamline CE marking and regulatory approvals.
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EU Authorized Representative and UK Responsible Person service supporting non-EU medical device manufacturers with regulatory compliance, CE marking, EUDAMED registration, technical documentation review, and Quality Management System establishment for European market access.
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European Authorized Representative and regulatory compliance service for medical devices and IVDs. Provides in-country representation across EU, UK, Switzerland, USA, and Australia to ensure manufacturers meet MDR, IVDR, AI Act, and GDPR requirements.
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