#11 The Emergence of SaMD with Mike Pogose, at what point is a software considered a medical device and how they are regulated

Mike Pogose is a Senior Quality & Regulatory Consultant at Hardian Health, a digital health consultancy specialising in Clinical, Regulatory, Health Economics and Investment. Mike has been in the MedTech industry for several years initially starting as an engineer in industrial metrology and mechatronics. In this episode he discusses how software medical devices are regulated around the world, the unique challenges a SaMD product faces in comparison to traditional devices, his advice for software companies and his journey starting as a software and systems engineer, eventually transitioning into MedTech. Get in touch with Mike Pogose - https://www.linkedin.com/in/michaelpogose/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical  Subscribe to the Podcast