in this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from Medical Device HQ will explain to us what you should consider when you have a SOUP within your product.
SOUP is the acronym for Software Of Unknown Provenance. This is mainly a piece of software that you want to use on your Medical Device but that you have not developed yourself. So if you have such thing, then you need to listen to this podcast episode with Christian Kaestner from Medical Device HQ.
►Who is Christian Kaestner?
Christian Kaestner is a highly skilled professional with over 25 years of experience in the medical device field. As a software developer with a deep interest in medical device software, Christian has the technical background to understand software development.
Christian was on the project teams that authored IEC 62304 and IEC 82304-1, so he has in-depth experience working with standards. If you're looking to improve your team's knowledge and skills, Christian offers online courses through Medical Device HQ to keep you up-to-date with industry best practices. He can also guide you in setting up your development process to comply with relevant standards.
Visit medicaldevicehq.com to learn more, and feel free to connect on LinkedIn.
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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
LinkedIn: [ Ссылка ]
I’m happy to answer short follow-up questions through LinkedIn messages.
Blog post on how to manage SOUPs: [ Ссылка ]
Medical device resources on YouTube: [ Ссылка ]
Playlist with medical device software videos on YouTube:
[ Ссылка ]
Link to SaMD course:
[ Ссылка ]
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► Social Media to follow
■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]
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#easymedicaldevice #medicaldevice #regulatorycompliance
