What are the changes to the risk management standard for medical devices in ISO 14971:2019? How should its companion guidance document, ISO TR 24971, be applied?
Watch this video for the answers to those questions, presented by Edwin Bills, an international member of the technical committee responsible for the latest revision ISO 14971 risk management standard.
In this video you'll learn about the new structure of these key industry artifacts, how these two documents have changed from previous versions, and unlock previously confidential insights into how you can best utilize the updated guidance for application to your own risk management and improve overall quality system processes for safer medical devices.
★ KEY VIDEO TAKEAWAYS ★
— Deep dive into the new changes of ISO 14971:2019 and ISO TR 24971
— Reasons for changing the risk management standard for medical devices
— How your medical device company can prepare and implement the new changes within your quality management system (QMS)
This presentation originally aired during the Greenlight Guru True Quality Virtual Summit. It included talks from over thirty of the top medical device experts from around the world presenting on top topics segmented into three main focus tracks:
1) GO Track - Covering everything you need to know to get new devices to market with less risk
2) GROW Track - Covering proven best practices for advancing the success of your devices already on the market
3) COVID-19 Track - Covering practical insights into managing and leading medical device companies and teams during the pandemic
The video you’re watching now is from our GO Track. If you’d like to watch more related videos, browse through the full list of free replays from this track of the True Quality Virtual Summit event: [ Ссылка ]
Plus, download the slides from this presentation for free here: [ Ссылка ]
Additional resources just for you:
— Get your free demo of Greenlight Guru's Medical Device QMS software: [ Ссылка ]
— SUBSCRIBE to our channel with 1-click: [ Ссылка ]
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