SaMD international reach – What to consider?
We are in a global world, so normally what is good for the EU can be also good for other countries. But here the only barrier is local law. This is mainly what we will discuss on this Podcast. We will use the example of SaMD or Software as a Medical device for it and share with you the experience that we have but this is applicable to nearly all medical devices. Check the podcast page at: https://podcast.easymedicaldevice.com/220-2/
► Who is Stéphane Berger?
Holder of a diploma in Electronics, with an experience of 25 years in the industry, after 10 years in the semiconductor field service business, he entered the medical device world in an ultrasound imaging company and started to implement ISO13485 requirements as customer service director and operation director. He began his career in quality and regulatory affairs in a recognized Notified Body with a position of auditor specialized in medical devices and software. He is currently holding the position of Regulatory and Quality Affairs Manager at Avicenna.AI, a French start-up that provides artificial intelligence solutions for radiology. Their products are registered in more than 40 countries worldwide and follow the evolving world of regulation around the Artificial Intelligence and Medical Device markets.
► 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.
► Links from the Video
■ LinkedIn Profile of Stéphane Berger: https://www.linkedin.com/in/bergerstephane
■ Avicenna Website: https://avicenna.ai/
■ WHO listing of Worldwide requirements: https://apps.who.int/iris/rest/bitstreams/1480622/retrieve
■ Authorized Representative Service: https://easymedicaldevice.com/authorised-representative-and-importer/
► Social Media to follow
■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
#easymedicaldevice #medicaldevice #regulatorycompliance