Regulatory compliance software and consulting services for medical device and IVD manufacturers navigating MDR and IVDR requirements. Provides strategic guidance and hands-on implementation support to accelerate market authorization and ensure regulatory adherence throughout product lifecycle.
Manufactured by
Metecon GmbH
Mannheim, Germany
Metecon is your strong partner for regulatory compliance in medical technology. For more than 25 years, we have been supporting manufacturers of medical devices and IVDs in meeting complex regulatory requirements, providing practical solutions for every stage of the product lifecycle. Whether strategic consulting, workshops, or hands-on support – our goal is to develop feasible solutions together with you that save time and resources. Our interdisciplinary team is fully committed to ensuring your regulatory compliance efficiently and sustainably. Let s tackle your challenges together – we look forward to meeting you!
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SigmaTech Nordic
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SigmaTech Nordic · Denmark
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 devices across Europe.
Maven Profcon Services LLP · India
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seleon GmbH · Germany
Medical software consulting services for medical device companies covering development, manufacturing, and regulatory compliance. Expert guidance from engineers, physicians, and quality management specialists with extensive international project experience in complex medical technology systems.
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