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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.

UDEM A.Ş. Featured in the 2026 Issue of Sağlık Dergisi

UDEM A.Ş. Featured in the 2026 Issue of Sağlık Dergisi

UDEM A.Ş. has been featured in the 2026 issue of Sağlık Dergisi, presenting its extensive experience in the medical device sector, its designation under Regulation (EU) 2017/745 (MDR), and its ongoing activities at both national and international levels.

UDEM A.Ş. Took Part in Expomed Eurasia 2026

UDEM A.Ş. Took Part in Expomed Eurasia 2026

As UDEM A.Ş., we were pleased to take part in Expomed Eurasia 2026, one of the leading meeting points for the medical and healthcare sectors.
 

As UDEM A.Ş., we celebrated International Women’s Day together with our female colleagues whose dedication, expertise, and productivity add value to our organization.

As UDEM A.Ş., we celebrated International Women’s Day together with our female colleagues whose dedication, expertise, and productivity add value to our organization.

UDEM at WHX Dubai 2026

UDEM at WHX Dubai 2026

As UDEM, we are proud to take part in WHX (World Health Expo) Dubai 2026, one of the most important events in the global healthcare sector.

UDEM Inc. Hosts Delegation from the Medical Device Authority of the Malaysian Ministry of Health

UDEM Inc. Hosts Delegation from the Medical Device Authority of the Malaysian Ministry of Health

UDEM A.Ş. hosted the Medical Device Authority (MDA) Malaysia and an accompanying high-level delegation at its office, with the aim of strengthening cooperation between Türkiye and Malaysia in the fields of medical device regulations and conformity assessment.

UDEM A.Ş. Career Page is Now Live!

UDEM A.Ş. Career Page is Now Live!

As UDEM A.Ş., we continuously advance our digital infrastructure and accessibility, striving to render our human resources processes more effective and transparent.

In line with this commitment, we have launched a brand-new "Careers" section on our corporate website: https://hr.udem.com.tr/

UDEM A.Ş. Connects with the Global Healthcare Sector at WHX Miami 2025

UDEM A.Ş. Connects with the Global Healthcare Sector at WHX Miami 2025

As UDEM Uluslararası Belgelendirme Den. Egt. Merk. San. ve Tic. A.Ş., we participated in the WHX Miami – World Health Exhibition (formerly known as FIME), held at the Miami Beach Convention Center from June 11 to 13, 2025.

UDEM A.Ş. Meets with the Dental Sector at IDEX Istanbul 2025

UDEM A.Ş. Meets with the Dental Sector at IDEX Istanbul 2025

As UDEM A.Ş., we took our place at the IDEX International Dental Exhibition and Conference, held at the Istanbul Expo Center from May 7 to 10, 2025. During this prestigious event—one of the dental industry's most significant gatherings—we had the opportunity to connect with local and international companies operating in the field of oral and dental health.

UDEM A.Ş. Attracts Intense Interest at Expomed Eurasia 2025

UDEM A.Ş. Attracts Intense Interest at Expomed Eurasia 2025

We were delighted to welcome numerous domestic and international visitors to our booth at the Expomed Eurasia 2025 exhibition, which took place at the TÜYAP Fair and Congress Center from April 24 to 26, 2025.

During the exhibition, we had the opportunity to establish direct contact with industry professionals, took significant steps toward new collaborations, and further solidified our position in the global market through the strong feedback we received. As UDEM A.Ş., we remain firmly committed to delivering sustainable and value-creating solutions that shape sectoral developments.

March 8 International Women's Day – Emphasizing the Value and Labor of Women

March 8 International Women's Day – Emphasizing the Value and Labor of Women

In celebration of this year's March 8 International Women's Day, we prepared and shared a special video on our social media platforms reflecting the value we place on our female workforce. This sincere and meaningful video received numerous positive responses, and it has been a source of great pride for us to share our corporate culture and the importance we attach to women's labor with the public.

Reduce Your Carbon Footprint, Protect the Future

Reduce Your Carbon Footprint, Protect the Future

In collaboration with UDEM Certification and GUTcert GmbH: Reduce Your Carbon Footprint, Protect the Future!

UDEM IT Department

UDEM IT Department

In today’s digital world, security threats are rapidly increasing.

2024 Tüyap Fair

2024 Tüyap Fair

As UDEM Inc., with over twenty years of experience, we are positioned as one of the leading and pioneering organizations in the industry. Our company, which embraces quality, impartiality, and independence as indispensable values, provides conformity assessment services to medical device manufacturers under the Medical Devices Regulation (EU) 2017/745 as a Notified Body (Notified Body 2292).

Our Notified Body Opinion Service, Which We Offer Within The Scope Of Article 117 Of (EU) 2017/745 Medical Device Regulation, For Manufacturers To Market Their Drug-Device Combination Products As An Integrated Device

Our Notified Body Opinion Service, Which We Offer Within The Scope Of Article 117 Of (EU) 2017/745 Medical Device Regulation, For Manufacturers To Market Their Drug-Device Combination Products As An Integrated Device

Article 117 of (EU) 2017/745 Medical Device Regulation (MDR) requires manufacturers who market drug-device combination products as an integrated device...

MDR Transition Process FAQs

MDR Transition Process FAQs

The Turkish Medicines and Medical Devices Agency has published answers to frequently asked questions regarding the extension process under Regulation (EU) 2023/607. 

MDR Transition Process

MDR Transition Process

With the Regulation (EU)2023/607, the validity periods of MDD certificates have been extended, provided that certain conditions are met.

MDR Technical Documentation Content Guide

MDR Technical Documentation Content Guide

You can access the Technical Documentation Content Guide, which we have prepared for the purpose of informing manufacturers, taking into account the MDCG 2022-14 guide and referencing the Team-NB Position Paper...

Legal Notification for the MDR Process

Legal Notification for the MDR Process

You can have a look at the details of our new to see the Announcement Notification for the Medical Device Arrangement Process.

Announcement on the Significant Changes in the MDR Process

Announcement on the Significant Changes in the MDR Process

As of May 26, 2021, Approved Institutions appointed under 93/42/EEC Directive will not be able to have another first certification but it has been announced...

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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