What is changing in the UK MDR?
MHRA organised a very informative webinar on 5th of Mar 2024 to provide update on the upcoming changes in the UK Medical Devices Regulation (UK MDR). They mentioned several reasons…
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The Latest Pilots from MHRA in 2023 and How They Could Help You
There are a lot of pilots that MHRA started back in 2023. This is a short summary of the new initiatives and how they can be helpful for pharma and…
Continue readingOur statistics for 2022-2023
The last year has been very successful for our team. We are grateful that in such challenging times for many businesses, we had the opportunity to set up and manage…
Continue readingOverview of the main points of FDA Informed Consent Guidance released in Aug 2023
FDA have released a final guidance regarding informed consent requirements for clinical trials. This guidance is applicable not only for medicinal products but for medical devices too. In this summery…
Continue readingWHO consultation on clinical trials (2023): Main Points and Analysis
There is an ongoing public consultation by the World Health Organization which aims to update its guidelines on clinical trials. There are some really good recommendations in the draft guideline…
Continue readingWriting Informed Consent for Medical Device Clinical Trials
There is a growing number of medical device clinical trials globally. While they have lots of similarities in terms of study design and documentations to drug clinical trials, medical device…
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