We continue to be the choice of professionals.

Independent and Impartial Conformity Assessment under the MDR
We conduct your conformity assessment processes under the EU Medical Device Regulation (EU) 2017/745 with our experienced team and a service approach based on international standards.
Value-Added Service with an Expert Team
With our experienced auditors and expert staff, we deliver professional solutions that not only assess conformity but also contribute to the quality processes of organizations.
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Impartial, Reliable, Competent

UDEM System and Product Certification Services

Having adopted providing customer-oriented services as a principle since its foundation, UDEM invests in technology, trainings and its personnel to keep customer satisfaction at its best in order to be able to accomplish its goal.

UDEM has set it as its goal not only to just control and confirm but also to provide added value to the systems of the firms it provides services for seeing them as its business partners while carrying out its activities without making concessions from impartiality. Accordingly, our experts have been selected from among experts capable of making comments from an objective perspective by combining experience with knowledge, generating solutions with constructive approaches and guiding the companies it provides services for in the activation of their systems,

UDEM System and Product Certification Services
Established 2004
Certificates Issued

Certification processes were successfully completed in compliance with applicable standards.

Clients Served

Professional services were provided to thousands of organizations across various industries.

Years of Experience

Extensive experience and expertise were gained in the field of certification.

Core Service Areas

Management system certification, product certification, testing, and measurement services were provided.

Hizmetler
Management System Certification
ISO 13485 Medical Devices – Quality Management Systems

UDEM is accredited by TÜRKAK for the ISO 13485:2016 Medical Devices Quality Management System standard. This standard covers quality, reliability, and regulatory compliance processes related to the manufacture of medical devices and associated services. ISO 13485 certification helps organizations standardize their processes, improve product quality, strengthen customer confidence, and gain a competitive advantage in international markets.

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Hizmetler
Product Certification

Expert Assessment in Product Safety

Product certification is an important assessment process that verifies products’ compliance with applicable standards, technical regulations, and legal requirements. Through its impartial and independent approach, UDEM evaluates products against quality, safety, and conformity criteria, helping companies build credibility and trust in the marketplace.

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Hizmetler
Testing and Measurement Services

Technical Assessment for Reliable Results

Testing and measurement services are essential quality control processes conducted to assess whether products, systems, or processes comply with applicable standards and technical requirements. Through its reliable testing and measurement infrastructure, UDEM helps companies verify product performance, ensure regulatory compliance, and build trust in the marketplace.

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Certification Services
We provide reliable and impartial certification processes in compliance with applicable standards.
01
Management System Certification

We provide impartial certification processes that assess organizations’ management systems in accordance with national and international standards.

02
Product Certification

By assessing products’ compliance with applicable standards, regulations, and technical requirements, we support reliable market access.

03
Testing and Measurement Services

We provide reliable testing, measurement, and conformity assessment services to verify the technical performance of products and processes.

We provide reliable and impartial certification processes in compliance with applicable standards.
UDEM NEWS
We have compiled the latest news from UDEM and the industry for you.
UDEM A.Ş. Featured in the 2026 Issue of Sağlık Dergisi

UDEM A.Ş. As, we took part in the 2026 issue of Health Magazine with our more than 20 years of experience in the medical device industry, our competence within the scope of MDR and our global activities.

UDEM A.Ş. Took Its Place at 2026 Expomed Eurasia Fair

UDEM A.Ş. We were pleased to take part in the 2026 Expomed Eurasia Fair, one of the leading meeting points of the medical and healthcare industry.

UDEM A.Ş. As, we celebrated March 8, International Women's Day, together with all our female colleagues who add value to our organization with their efforts, knowledge and productivity.

The strong presence of women in the workforce is one of the most important drivers of production, development, and sustainable success. As the UDEM Inc. family, we are proud of the strong representation of our female employees within our organization and deeply value being an institution that continues to grow through their contributions.

UDEM at WHX Dubai 2026

As UDEM, we took our place at WHX (World Health Expo) Dubai 2026, one of the most important events of the world health industry.

UDEM A.Ş. Hosted the Malaysian Ministry of Health Medical Device Authority Delegation

UDEM A.Ş. In order to improve cooperation between Turkey and Malaysia in the fields of regulation and product evaluation for the medical device sector, the Medical Device Authority Malaysia of the Ministry of Health and its accompanying high-level delegation were hosted in the office.

Udem Inc. Career Page is Online!

UDEM A.Ş. As, we constantly improve ourselves in the field of digitalization and accessibility and continue to make our human resources processes more effective and transparent.

Udem A.Ş. Met with the Global Health Sector at Whx Miami 2025

UDEM International Certification Den. Egt. Center. Singing. and Tic. Inc. As, we attended the WHX Miami - World Health Fair (formerly FIME) event held at the Miami Beach Convention Center on 11-13 June 2025.

Udem A.Ş. Met with the Dental Sector at İdex Istanbul 2025

UDEM A.Ş. at the IDEX International Dental Fair and Conference held at Istanbul Expo Center between 7-10 May 2025. We took our place as

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

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 Carbon Footprint, Protect the Future

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

UDEM IT Department

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

2024 Tüyap Fair

As DEM Inc., with over twenty years of experience, we are positioned as one of the leading and pioneering companies in the industry.

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

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

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

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

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

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...

Professional Team, Reliable Service
Your Solution Partner for National and International Standards
UDEM Blog
We have compiled everything you need to know.
Document on Machinery CE Marking

Machinery CE Marking Certificate is the certification processes carried out within the framework of the conditions imposed by the European Union.

Attention Forklift Manufacturers and Importers!

Ensuring the safe and efficient use of forklifts is of critical importance for manufacturers and importers. At this point, legal compliance and compliance with technical standards of forklifts are inevitable.

What is (EU) 2017/745 Medical Device Regulation (MDR)?

(EU) 2017/745 Medical Device Regulation (MDR) was published in the official journal of the European Union on 05.05.2017 and was put into practice as of 26.05.2020.

For Detailed Information

Get in Touch With Us

Reach out with your questions; our team is ready to help.

UDEM Systems & Product Certification Services


We crown our achievements with originality with our sector experience and expert personnel, 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 Turkey, but also in the global market, we are expanding our international network every day.

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