About Fabien Lombardi

Fabien Lombardi is a medical device R&D leader and consultant with more than 25 years of experience developing complex implantable and catheter-based technologies, with a focus on structural heart devices, delivery systems, heart valves, and vascular implants.

Former Vice President of R&D and engineering leader in Switzerland, France, the United States, the United Kingdom, and Australia. Expertise includes R&D strategy, design verification, risk management, ISO 13485 QMS, manufacturing transfer, clinical support, and technical due diligence.

Fabien is listed as an inventor or co-inventor on 18 patents and patent applications related to implantable cardiovascular devices and delivery systems.

• Structural heart and cardiovascular devices

• Delivery systems, catheters and stent-based implants

• Verification, validation, risk and quality systems