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“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 [...]

A New ISO 18969

A New ISO 18969 – “Clinical Evaluation of Medical Devices” Is on the Way: Understanding [...]

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 [...]

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 [...]

Clinical Evaluation and Sufficient Clinical Evidence

Clinical Evaluation requirements have increased dramatically. The process now involves three documents: the Clinical Development [...]

What a CTA can accomplish for you

My name is Nicole and I am working as a Clinical Trial Assistant (CTA) at [...]

Updated IMDRF guidance on PMCF studies

On 20 May the IMDRF posted an updated guidance on Post-Market Clinical Follow-up (PMCF). Guidance [...]

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 [...]

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 [...]

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 [...]