In today’s video I will briefly answer the following question:
“Why and how should quality management principles be applied in your clinical investigation?”
The inclusion of guidance with regards to clinical quality management, is one of the main changes to the new version of the ISO14155.
Why? To ensure that the clinical investigation is compliant to the ISO14155, the Clinical Investigation Plan and any other applicable standards and regulatory requirements, quality management principles should be applied to the processes of the clinical investigation.
How? Sponsors apply these principles by implementing and maintaining written clinical quality procedures, documenting its compliance to these procedures, and ensuring that all auditing requirements are met.
The clinical quality procedures can be integrated in the applicable sections of the sponsor’s overall quality system.
Outro: Looking for In-Depth ISO14155:2020 training? Have a look at www.academy-riannetooten.nl/courses.