Applicability of ISO14155 to Post Market Clinical Trials

In this video I’m going to briefly answer the following question:

 

“Is the ISO14155 applicable to the post-market stage of your clinical trial?”

 

Transcript:

In today’s video I’m going to briefly answer the following question:

“Is the ISO14155 applicable to the post-market stage of your clinical trial?”

 

In the latest 2020 version, Annex I brings welcome clarifications on the applicability of the requirements of this standard to the different clinical development stages.

It also includes a useful table for the planning and design of clinical investigation in all phases of the medical device lifecycle.

Annex I clearly emphasize on the fact that the ISO14155 is applicable to all clinical development stages, but also clearly points out which exemptions can be made when getting into the post-market stage and asks for a clear justification to be given for each exemption.

So yes, the ISO14155 is applicable to the clinical post-market stage whether or not with some possible exemptions.

Would you like to know which exemptions are allowed for the post-market stage, get yourself a copy of the standard or trained on it.

 

Share This Post

Other articles

Clinical Investigations

What has changed in the new ISO14155:2020 standard?

The ISO14155 provides an important guide on the use of Good Clinical Practice in clinical investigations. In the ISO14155 you’ll find the main requirements to: protect the well-being, safety and rights of human subjects in the clinical investigation; assure the scientific relevance of the investigation and the trustworthiness of its results; define what the sponsor

Video

Harmonization EC approval process

In today’s video, I will briefly answer the following question:   “How is the approval process of Ethics Committees harmonized under the MDR?”      Transcript:   Ethics committees are responsible for evaluating a clinical investigation and determine whether ethical principles are being met. Requirements related to ethics committee composition and function are not specified in the

Scroll naar top