MedTech Safety
Bio
Karandeep is a seasoned Quality and Regulatory expert with nearly a decade of experience in the medical device industry. He specialises in Quality Management Systems (QMS), ISO 13485, MDSAP, EU MDR, UK MDR, CFR 820, and FDA pathways, including 510(k) and De Novo submissions. As a CQI/IRCA Lead Auditor, Karandeep brings a wealth of expertise in ensuring compliance, streamlining regulatory processes, and driving excellence in global medical device regulations.
Karandeep is recognised as a thought leader in his field, having been featured in CQI/IRCA articles and the British Journal of Hospital Medicine. He is the host of The MedTech Podcast, where he engages with leading industry professionals to discuss critical issues and innovations in the MedTech sector. Karandeep is also an active LinkedIn content creator, sharing his knowledge and insights on quality and regulatory affairs to foster meaningful discussions and drive industry progress.
Karandeep is a regular speaker at medical device events, known for delivering practical guidance on quality systems, regulatory compliance and adapting to evolving global standards. His mission is to empower organisations to bring innovative medical devices to market while maintaining the highest standards of quality and safety.