Metecon GmbH - your regulatory compliance partner. For more than 25 years we have been supporting manufacturers of medical devices and IVDs with reliable solutions in QMS, Clinical Affairs, Regulatory Affairs and PMS. Tackle regulatory challenges efficiently with Metecon - let's get in touch!
Metecon is your trusted partner for regulatory compliance in the medical device industry. For more than 25 years, we've helped medical device and IVD manufacturers navigate complex regulatory challenges, providing practical solutions for all phases of the product lifecycle.
Our Expertise Includes:
Technical Documentation
Comprehensive strategic consulting and hands-on support for the creation and ongoing maintenance of technical documentation, including risk management, usability, and biological safety.
Quality Management
Quality management services for Europe and global markets; QM processes according to ISO 13485, GxP, internal audits, management reviews, certification support, and proficient communication with notified bodies.
Verification and Validation
Documentation and follow-up documentation of requirements specifications, functional specifications, V&V plans and reports, risk management; traceability documentation; support for preclinical testing; design history file.
Clinical Affairs, PMCF/PMPF and PMS
Clinical evaluations and efficient strategies for updates throughout the product lifecycle; customized strategies and active support for meeting PMCF/PMPF and PMS requirements.
Global Market Access
Tailored strategic consulting and precise support for country-specific registrations worldwide, ensuring compliance and smooth market entry across diverse regulatory landscapes.
Representative Services as EC-REP and CH-REP
Reliable representative services that facilitate seamless market access for your products, ensuring regulatory compliance across the EU and Switzerland (CH-REP/EC-REP).
Software and Digitization
Expert consulting and comprehensive support for all regulatory tasks related to software and AI, ensuring compliance and innovation stay aligned.
Whether it's strategic consulting, customized workshops or hands-on operational support, our goal is to work with you to create effective, resource-saving solutions. Our multidisciplinary team works flexibly and in partnership to address your regulatory needs in an efficient and future-proof manner.
Let's tackle your challenges together - we look forward to working with you!
Further information:
Services for your medical device
Metecon blog: Regulatory affairs updates for medical devices and IVDs
