Dr. Michael Gschwandtner

Anteris medical GmbH

Michael is the Co-Founder of Anteris Medical. He is a medical device professional with more than 14 years’ experience in mid-size and global biotech and device organizations in the fields of development, quality and regulatory affairs including Electrical Medical Devices (class II and III) comprising sw, electronics hw, Medical Software Products and Drug Delivery Systems for biologics (Autoinjectors / Needle Safety Devices).
Michael is a certified lead auditor for ISO 13485 (British Standards Institute) and leads the set up of ISO 13485 QM systems within organizations ranging from start-ups to global pharma companies. He was involved in International Project Management for various Medical Device Development Projects from Kick Off till Commercialization (EU / US / Asia) and is an expert in US and EU compliant processes for Requirements Engineering, Verification / Validation, Usability and Risk Management.
He has a strong focus on Design Control, Regulatory Affairs and Quality Management for combination products and stand-alone medical devices.