Importance of Validation and Reference Standards in ML Models

You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy.
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► Who is Richie Christian?
Richie Christian has more than 10 years of experience in medical device regulatory and quality. He has a Master’s degree in neurophysiology from the University of Auckland, and is passionate about digital transformation of the healthcare industry. Throughout his career, Richie has worked in numerous regulatory and quality roles with not only traditional hardware device manufacturers, but also cutting-edge AI/ML-enabled SaMD manufacturer.
In his most recent role as the Head of Regulatory and Quality, he spearheaded the development and implementation of a streamlined QMS, enabling them to achieve MDSAP certification and secure market authorisations for an innovative orthopaedics AI/ML-enabled SaMD in USA and Japan.
Richie relocated to Basel, Switzerland from New Zealand as a consultant for wega Informatik where he now applies his decade-long experience to help companies develop and deliver compliant medical device software.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video
•Richie Christian Linkedin Profile: / christianrichie
•Wega Website: www.wega-it.co...
•AAMI/BS standard knowledge.bsig...
•Good Machine Learning Practice for Medical Device Development: Guiding Principles: www.fda.gov/me...
•Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles www.fda.gov/me...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance