Medical Device Certification
Medical Device Certification
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We provide end-to-end Medical Device Certification Services supporting manufacturers in achieving full compliance with EU MDR requirements. Start your compliance procedure today with our expert regulatory support.
Authorized Representation Services
Authorized Representation Services
Our Authorized Representation Services ensure full compliance with EU MDR requirements for non-EU medical device manufacturers. We safeguard regulatory continuity, documentation integrity, and post-market obligations on your behalf.
Market Access
Market Access
Our Market Access Services enable manufacturers to commercialize their products seamlessly across the European Union by combining regulatory compliance with established distribution capabilities. Expand your product sales across the EU with confidence.
Clinical Trials
Clinical Trials
We can coordinate tailored clinical investigations through a network of experienced CRO partners, including support for EU MDR Class III medical devices. We ensure regulatory-aligned study design, efficient trial execution, and compliant data generation to support conformity assessment.
Hospital Trainings
Hospital Trainings
Our Training Programmes for Nurses and Doctors provide structured, device-specific education on the safe use of novel medical devices in clinical settings. Training is aligned with EU MDR requirements and supports proper adoption and clinical performance optimization.
Upcoming Event
Upcoming Event
Meet our team at the Dubai World Health Expo 2026, where we will present our regulatory, certification, and market access services for medical device manufacturers. Connect with us in person to discuss EU MDR compliance, clinical strategies, and European market entry.
CONTACT
CONTACT
UNITED STATES, Tucson AZ
T: +1 602 820-7377
EUROPEAN UNION, Budapest
T: +36 300 901-320
CANADA, Toronto
T: +1 613-941-5366
ASIA–PACIFIC, Seoul
T: +82 10-7650-7749
For general enquiries please email us at
INFO @ FENARIS.COM
ABOUT US
The Fenaris Alliance operates at the nexus of innovation and influence, guiding Asian companies on their journey to penetrate global markets. Our footprint spans across Europe, the USA, the Middle East, India, and Africa, driving access to critical procurement channels and facilitating seamless market entry. We are more than just a business facilitator. We are a network with deep governmental, political, and strategic military ties.
During the pandemic, when the world faced critical shortages, our expertise came to the forefront. Fenaris representatives were pivotal in the central procurement of vaccines, personal protective equipment, and medical supplies, forming essential partnerships with hospitals and supply chains globally. Today, we continue that legacy, connecting Asian innovators in sectors as diverse as pharmaceuticals, medical devices, and cutting-edge technologies to the world’s most complex markets.
Our Alliance is about opportunity, strategic access and direct connections in the global market.
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