Regulatory consulting and quality management service for medical device and IVD compliance under MDR and IVDR frameworks. Provides strategic guidance and hands-on support for market authorization and post-market surveillance. Leverages 25+ years of expertise and 60+ regulatory specialists.
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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3R LifeScience GmbH · Germany
Quality management and regulatory consulting service supporting medical device manufacturers in MDR compliance, CE marking, and regulatory documentation. Provides expert guidance on risk management, development processes, and quality system optimization to ensure safety and performance requirements are met.
BEO MedConsulting Berlin GmbH · Germany
Regulatory consulting and quality management system implementation for medical device manufacturers. Supports EU-MDR 2017/745 compliance assessments, conformity documentation, and QMS establishment. Includes regulatory documentation, expert evaluations, and audit coordination to ensure product safety and market authorization.
BioTop Medical Dr. Teresa Lopes · Netherlands
Regulatory compliance and quality management consulting service for medical device manufacturers. Supports development of technical documentation, risk management files, and post-market surveillance plans required for European and North American market authorization. Provides hands-on management of regulatory affairs and quality assurance activities throughout device lifecycle.
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