Regulatory representation services for medical devices and IVDs under MDR, IVDR, and related frameworks. EC-REP, CH-REP, and PRRC designation support enables market access and compliance across EU and international jurisdictions. Expert guidance on regulatory strategy, documentation, and post-market...
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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ASPHALION, S.L · Spain
Regulatory Affairs and Post-Market Regulatory Compliance (PRRC) consulting services for medical devices and pharmaceuticals. Provides expert guidance through product development, regulatory procedures, dossier preparation, and post-market vigilance across EU and international markets. Supports compliance with evolving regulatory standards and streamlines market authorization pathways.
BYTEC Legal Manufacturer GmbH · Germany
MDR consulting, quality management system (QMS) development, and regulatory compliance support for medical device manufacturers. Services include EC-Representative functions, pre- and post-market authorization guidance, and audit preparation to facilitate CE marking and ongoing regulatory adherence throughout device lifecycle.
MedNet EC-REP GmbH · Germany
European Authorized Representative (EU-REP) service providing regulatory compliance and market access support for medical devices, IVDs, cosmetics, and PPE across EU, UK, and Switzerland. Enables manufacturers to meet MDR 2017/745, IVDR 2017/746, and GPSR requirements for all device classes.
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