ISO 14155 – GCP for Medical Devices – Latest Updates
As part of any International Standard process, ISO 14155 is currently undergoing its periodic review including quite a few important updates. The document is aimed at providing GCP guidance for the international medical device clinical professional community with an increasing global acceptance by regulators.
Important updates are being finalised including reinforcement of risk management throughout all aspects of a medical device clinical investigation, risk based monitoring, guidance on level of application of the standard’s requirements to the different types of medical device study types as well as additional guidance for ethics committees and more.
Some changes in the document are also triggered by the new regulations and guidance documents that were published in Europe and the US, as the main goal of the working group is to ensure the document keeps its global acceptance level.
The presentation will provide a comprehensive overview of the important upcoming changes in the document which will most likely become into force towards the end of 2018 early 2019. This is an excellent opportunity for medical device clinical professionals to keep up to date and be prepared.