Comprehensive technical documentation services for medical device regulatory compliance under MDR and IVDR frameworks. Supports manufacturers in preparing, organizing, and maintaining regulatory documentation required for market authorization and post-market surveillance.
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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BioTop Medical Dr. Teresa Lopes
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BioTop Medical Dr. Teresa Lopes · Netherlands
Comprehensive technical documentation service supporting medical device regulatory compliance. Includes literature search reports, clinical and performance evaluations, biological assessments, usability engineering documents, risk management files, post-market surveillance plans, and periodic safety updates for European and North American market approval.
KCL · South Korea
Expert review and assessment of medical device technical documentation for regulatory compliance. Supports manufacturers in preparing quality submissions.
provita medical gmbh & co. kg · Germany
Documentation and support services for medical device regulatory compliance, assisting manufacturers in meeting quality and safety requirements for device certification and market approval.
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