MD & M West 2024German Exhibitors Metecon GmbH
Metecon GmbH
Booth number: 3156
www.metecon.de
About us
To legally market medical devices and IVDs, manufacturers must meet complex regulatory requirements, including MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostics Regulation) for Europe and country-specific regulations for other markets.Metecon offers a comprehensive suite of compliance services throughout the entire product life cycle. Our expertise spans from MDR and IVDR-compliant technical documentation and the maintenance of existing devices and IVDs to market entry into new territories, post-market surveillance (PMS and PMCF/PMPF), and the optimization of your quality management processes.
Our team of over 60 regulatory compliance professionals ensures we have the expertise and manpower you need. Our focus is to facilitate market entry and maintain certifications for medical device and IVD manufacturers.
Discover what Metecon can do for you – we're excited to meet you!
Address
Metecon GmbH
Q7 21
68161 Mannheim
Germany
Phone: +49 621 123469-00
Q7 21
68161 Mannheim
Germany
Phone: +49 621 123469-00
Contact person:
Alexander Fink
Founder and CEO
E-mail: alexander.fink@metecon.de
Phone: +49 621 12346900
Jörg Ohmer
Head of Business Development
E-mail: joerg.ohmer@metecon.de
Phone: +49 621 12346914
Marco Scicolone
Business Development
E-mail: marco.scicolone@metecon.ch
Phone: +41 7986 82020
Products & Services
Our expertise spans every aspect of Regulatory Compliance, such as:Technical Documentation: We specialize in creating and maintaining MDR/IVDR-compliant technical documentation, ensuring your products meet the highest regulatory standards.
Quality Management: Our team helps you establish, optimize, and audit your quality management processes, ensuring they align with the latest regulations.
Regulatory Consultation: We provide strategic market access planning and execution, helping you navigate complex regulatory landscapes effectively.
Clinical Evaluation: Metecon assists with clinical investigations and PMCF/PMPF planning, ensuring your products are supported by robust clinical data.
Post-Market Surveillance: Our experts support in establishing and implementing systems for monitoring and reporting the performance of your devices, ensuring compliance, and addressing issues promptly.
Uncover how we can simplify regulatory compliance, reduce risks, and accelerate your market access.
Representative Services
For market access in the EU and Switzerland the Authorized Representative plays a crucial role for non-EU manufacturers of medical devices and IVDs. The representative (EC-Rep and CH-Rep accordingly) is a legally responsible person based in the EU/Switzerland and represents the non-EU manufacturer to the local competent authorities.
Visit website Regulatory Consulting
Medical devices and IVDs can only be marketed successfully if you as a manufacturer meet the regulatory requirements of the target market. With us, you get the full range of compliance services to support you through the entire product lifecycle of your medical device or IVD: in technical documentation according to MDR/IVDR, in the maintenance of existing medical devices, in verification and validation, post market surveillance and in the optimization of your quality management processes.
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