If you are a medical device manufacturer/sponsor starting a clinical trial, you have the obligation [...]
A New ISO 18969 – “Clinical Evaluation of Medical Devices” Is on the Way: Understanding [...]
With the implementation of the Medical Device Regulation (2017/745) (MDR) in the EU, post-market clinical [...]
More and more focus has been given to the state of the art in the [...]
Clinical Evaluation requirements have increased dramatically. The process now involves three documents: the Clinical Development [...]
My name is Nicole and I am working as a Clinical Trial Assistant (CTA) at [...]
On 20 May the IMDRF posted an updated guidance on Post-Market Clinical Follow-up (PMCF). Guidance [...]
After many delays it now officially available: the new ISO14155 standard for clinical investigations of [...]
We are all familiar with the listings of side-effects in the package insert of medicines [...]
Investigator Initiated Studies (IIS) are clinical investigations that are started by physicians. As opposed to [...]
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