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
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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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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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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(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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