The professional personnel of UDEM, who are experts in their fields thanks to their professional experience, are qualified to respond to all kinds of needs relating to the related activities.
UDEM System and Product Certification Services
64086
Certificates issued
33585
Customers reached
20
Years of experience in the industry
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,
We have compiled the news about UDEM and the industry for you.
UDEM NEWS
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.
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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/
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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.
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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.
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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.
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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.
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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...
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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.
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MDR Transition Process
With the Regulation (EU)2023/607, the validity periods of MDD certificates have been extended, provided that certain conditions are met.
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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...
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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.
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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...
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(EU) 2017/745 Medical Device Regulation
In order to protect patient and user health, the European Union (EU) has made a major change in medical device directive with stricter requirements in order to improve quality, safety and performance data in medical devices and to harmonize all sector stakeholders, whether manufacturers, notified bodies or competent authorities.
Lift Directive 2014/33/AB
The aim of this directive is to determine the basic health and safety requirements to be met by lifts and lift security parts, requirements for introduction to the market relating to these products and principles of market surveillance and control.
With the knowledge and experience gained through years...
Services We, as UDEM, Offer to Our Customers
The professional personnel of UDEM, who are experts in their fields thanks to their professional experience, are qualified to respond to all kinds of needs relating to the related activities.
Services we, as UDEM, offer to our customers
We have compiled the things you should know for you
UDEM BLOG
MDR Process in Medical Devices
MDR is the name given to the practices know as Medical Device Regulations as a whole. This practice, which entered into force on May 25, 2017, is an arrangement introduced within the scope of reassessment of medical devices although their compliance has been certified before.
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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 Türkiye, but also in the global market, we are expanding our international network every day.
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