May 13, 2024
Medical Devices - EUDAMED
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746…
DNA Technologies is a international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries, specializing in clinical development and flexible resourcing solutions.
DNA Technologies has experience in conducting/monitoring clinical trials from Phase II to Phase IV and medical device clinical trials across most major therapeutic areas.
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The drug development pipeline can be long and arduous. Enormous amounts of time, money, and resources are required to bring an idea to patient.
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May 13, 2024
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746…
Mar 01, 2024
When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the clinical investigation is to be conducted, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR
Dec 12, 2023
A clinical investigation can demonstrate a medical device’s safety and clinical performance. In December 2023, the Medical Device Coordination Group updated the guidance on clinical investigation, MDCG 2021-6
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