praxis-text-mobile

News

ISO 14155:2020 update released!

Share This Post

Share on facebook
Share on linkedin
Share on twitter
Share on email

Clinical investigation of medical devices for human subjects — Good clinical practice (GCP for Medical Devices) has undergone a significant review.

The changes include;
— inclusion of a summary section of GCP principles
— reference to registration of the clinical investigation in a publicly accessible database
— inclusion of clinical quality management
— inclusion of risk-based monitoring
— inclusion of statistical considerations
— inclusion of guidance for ethics committees
— reinforcement of risk management throughout the process of a clinical investigation
— clarification of applicability of the requirements of this document to the different clinical development stages
— inclusion of guidance on clinical investigation audits

Never fear! Our team at PRAXIS are currently working with a team of Australian experts to bring you education resources to bring the #clinicaltrials sector up to speed on the new requirements.

#clinicaltrials #medicaldevices #GCP #ISOstandards #regulatory#education #praxisaus #fromcompliancetoexcellence

Link to full news article

Receive exclusive offers by signing up to our mailing list