Category Archives: Blog
“Monitoring of medical device clinical trials” in accordance with ISO14155 and EU MDR
If you are a medical device manufacturer/sponsor starting a clinical trial, you have the obligation [...]
Mar
A New ISO 18969
A New ISO 18969 – “Clinical Evaluation of Medical Devices” Is on the Way: Understanding [...]
Dec
Tips to Design a High-Quality PMCF User Survey
With the implementation of the Medical Device Regulation (2017/745) (MDR) in the EU, post-market clinical [...]
Nov
State of the Art: What does it Mean in Practice?
More and more focus has been given to the state of the art in the [...]
Oct
Clinical Evaluation and Sufficient Clinical Evidence
Clinical Evaluation requirements have increased dramatically. The process now involves three documents: the Clinical Development [...]
Sep
What a CTA can accomplish for you
My name is Nicole and I am working as a Clinical Trial Assistant (CTA) at [...]
Oct
Updated IMDRF guidance on PMCF studies
On 20 May the IMDRF posted an updated guidance on Post-Market Clinical Follow-up (PMCF). Guidance [...]
May
What are side-effects and what is their relationship to residual risk and adverse events?
We are all familiar with the listings of side-effects in the package insert of medicines [...]
Aug
The new ISO14155 standard for Good Clinical Practice is now published!
After many delays it now officially available: the new ISO14155 standard for clinical investigations of [...]
Jul
Investigator Initiated Studies, what are they and how can they be of value to your company?
Investigator Initiated Studies (IIS) are clinical investigations that are started by physicians. As opposed to [...]
Jul
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