QA training program supporting medical device companies in achieving CE marking compliance and ISO 13485 certification. Covers regulatory requirements, quality management systems, and documentation standards for diagnostic and therapeutic devices across European markets.
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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DQS Medizinprodukte GmbH · Germany
DQS Academy provides specialized training and certification programs for medical device manufacturers and healthcare organizations. Courses cover EU Medical Device Regulation (MDR) compliance, quality management systems (ISO 13485), and notified body assessment requirements. Delivered by industry experts with 40+ years of certification experience across 60+ countries.
CERTEAFILES SAS · France
Training and consulting services for medical device regulatory compliance, including technical documentation creation, MDR file management, and quality assurance strategies. Supports healthcare professionals in navigating EU 2017/745 regulations and preparing submissions for Notified Bodies.
EUCEREP B.V. · Netherlands
ISO 13485 Lead Auditor training course for medical device professionals. Equips quality and regulatory personnel with accredited credentials for implementing and auditing Quality Management Systems in medical device manufacturing. Includes theoretical knowledge and practical competency assessment aligned with international standards.
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