Category Archives: Blog

Achieving Regulatory Compliance Through Clinical Evaluation

By Jasmin Hunter, Senior Consultant Clinical evaluation is a process to collect and assess all [...]

“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 [...]

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 [...]

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 [...]

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