Traditional CROs fragment device development with costly hand-offs and learning curves. Veranex unites the essential disciplines for medical device & diagnostic development under one roof from sketch to evidence-generation to market launch.
All connected. All aligned. All accelerating your path to market—delivering breakthrough devices and diagnostics that improve patient lives sooner.
Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.
Purpose-built solutions. Proven results. User & Patient-centered innovation.
Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity. Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.
We are the Innovation CRO.
Legacy of excellence. Proven execution. Patient impact accelerated.
From early feasibility to commercialization, progress depends on the right decisions at the right time. Get confident in your next step with blogs, case studies, and expert insights that cut through complexity and move development forward.
Build practical understanding of IEC 62304 requirements for compliant medical device software development, validation, documentation, and lifecycle management.
Medical device software development requires more than technical execution.
Teams need a compliant process that connects regulatory strategy, software lifecycle planning, verification and validation, risk management, technical documentation, and cybersecurity.
This two-day training provides a complete overview of IEC 62304 implementation for software as a medical device and software integrated within medical devices. Participants will review the regulatory context, software-specific quality system expectations, and the practical requirements needed to implement a compliant software development process.
Regulatory professional with over 12 years of experience in medical devices. Areas of expertise include AI/ML, cybersecurity, data protection and evolving regulations (EU AI Act, NIS-2, GDPR/FADP), with strong focus on regulatory strategy and development, including V&V and Risk Management, both for EU and US markets. Fluent in English and Spanish.
Director, Quality and Regulatory Affairs - Head of QMS
Cédric holds a master’s in Microengineering from EPFL Lausanne and has worked in manufacturing engineering and product development. He is a Quality and Regulatory Affairs expert for medical devices and IVDs with 8+ years of experience in QMS implementation and regulatory submissions, including ISO 13485, ISO 27001, IEC 62304, and cybersecurity support in highly constrained environments. He is fluent in English and French, with a good understanding of German.
Learn from Specialists Who Work Inside Medtech Complexity Every Day
Talk with Veranex about upcoming training dates, private sessions, or tailored programs built around your organization’s device, IVD, regulatory, clinical, or quality needs.
