Lucendra is a Swiss-based full-service MedTech consulting firm, providing agile and pragmatic support to start-ups, SMEs, and strategic companies. We specialise in Quality, Regulatory, Clinical, Scientific and Digital Health services tailored for medical devices, including in vitro diagnostic devices, combination products, (active) implantable medical devices, substance-based devices, medical device software, AI/ML-enabled and wearable devices—spanning from low-risk to high-risk classifications. Our expertise extends to various medical specialties, including neurology, cardiovascular, orthopedics, dentistry, ophtalmology, gastroenterology, oncology, (robotic) surgery, rehabilitation, gynecology, anesthesiology and more. Whether you are a start-up navigating regulatory pathways, an SME refining your quality management system, or a strategic launching a complex AI/ML product, we are here to guide you every step of the way.
I am a physicist with a PhD in Biomedical Engineering and RAC (Devices) certification. I am supporting medical device manufacturers in Regulatory and Clinical Affairs, specializing in clinical strategies, regulatory pathways, and technical documentation for CE and FDA submissions.
As a start-up coach I support early stage Medical Device Start-Ups to navigate regulatory requirements, balancing efforts, resources and timelines.
I am pragmatic, focusing on tailored effective and compliant solutions to complex challenges.