Dr. Michael GschwandtnerCo-Founder and CTO

Michael is Co-Founder of anteris medical. He is a medical device professional with more than 12 years’ experience in mid-size and global biotech and device organizations in the fields 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).

He is a certified lead auditor for ISO 13485 (British Standards Institute) and sets up ISO 13485 QMS at a Big Pharma company including successful certification within 1 year.

Michael did International Project Management for 5 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.

Expertise:

  • Oncology/hematology (several)
  • Anti-rheumatics
  • Immunology
  • Injection systems (intravitreal)
  • Injection devices (autoinjectors, Pen systems, Needle guard systems)
  • Image Guided Surgery Systems