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(EU) 2017 / 745 Medical Device Regulation
(EU) 2017 / 745 Medical Device Regulation

UDEM Certificate

We continue to be the choice of professionals.

We specialize in ISO 13485 System Certification, CE Marking (CE in Machinery, CE in Lifts, CE in Building Materials, CE in Medical Devices), Ready-Mixed Concrete Certification/G Marking, and Training. Our commitment revolves around prioritizing customer satisfaction and trust in all aspects of our business. Explore our comprehensive range of services in the 'Our Accreditations and Authorities' section.

Our team at UDEM comprises dedicated professionals, each possessing extensive expertise in their respective fields. With a wealth of professional experience, our staff is well-equipped to address diverse needs related to our service offerings...

About Company

Udem - Your Trusted Partner for MDR Certification

At Udem, we understand the critical importance of Medical Device Regulation (MDR) compliance in the ever-evolving healthcare landscape. Our commitment to excellence and quality drives us to provide comprehensive MDR certification services for medical device manufacturers.

Why MDR Certification Matters?

The MDR represents a significant shift in the regulatory framework for medical devices within the European Union. Compliance with MDR is essential for ensuring the safety and efficacy of medical devices, enhancing patient and user safety, and facilitating market access.

Choose Udem as your trusted partner for MDR certification, and let's work together to ensure your medical devices meet the highest standards of safety and compliance.

"The certification process that adds value to your company."

News & Blog

We are helping our clients to prepare for the future.

Navigating the MDR Process in Medical Devices: A Comprehensive Overview

Navigating the MDR Process in Medical Devices: A Comprehensive Overview

In the ever-evolving landscape of medical device regulations, understanding the intricacies of the Medical Device Regulation (MDR) is paramount for manufacturers, stakeholders, and regulatory bodies alike. In this blog post, we delve into the course of proceedings under MDR, shedding light on the key aspects of the process.

UDEM Certificate

We crown our achievements with originality with our sector experience and expert staff, we continue to be the choice of professionals.

Without compromising our principles of impartiality, independence and confidentiality, we aim to be a leader not only in Türkiye, but also in the global market, we are expanding our international network every day.

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