GCP for Medical Devices ISO 14155:2020
*New in 2021!
Conducting medical device clinical studies according to Good Clinical Practice (GCP) is necessary – not only to ensure the collection of robust and reliable, high quality data that complies with research ethics principles, but also for regulatory compliance in Australia, the European Union (EU) and US, who all recognise the ISO 14155 standard for medical device trials along with other local requirements.
ISO 14155 was updated and released in 2020 to bring it into alignment to other related ISO standards. This workshop will give attendees a comprehensive understanding of the revised standard, its role and purpose and its application for both pre-market and post post-market clinical investigations with medical devices.
This 5-hour workshop is suitable for those working across the development lifecycle of Medical Devices including regulators, industry, researchers, research site staff and HREC and research governance personnel.
About the Facilitators
At the completion of this session, you will be able to:
This interactive workshop will include case studies and scenario-based examples to help attendees to better understand how to apply the ISO 14155:2020 standard to their work in practical and meaningful ways.
$550pp plus GST
Discounts apply for group bookings of 10 or more.
Dates & Locations
Tuesday, 11th May: 0900am – 1400pm AEST/AEDT
Tuesday, 13th July: 0900am – 1400pm AEST/AEDT
Tuesday, 14th September: 0900am – 1400pm AEST/AEDT
Tuesday, 16th November: 0900am – 1400pm AEST/AEDT
Need training on demand?
This session can also be conducted at your location for groups of 10 or more. Ask us about this today.
PRAXIS Australia has the right to cancel a workshop or training session (or move the event format online) due to unforeseen circumstances such as low registration/attendance numbers or changes in Government restrictions surrounding the ongoing COVID19 pandemic. For more information regarding our Cancellation Policy and your rights as a student, please see our Student Terms and Conditions document.