About this event
In vitro diagnostic (IVD) equipment plays a critical role in healthcare, where reliability and safety are non-negotiable. Ensuring compliance with essential safety, EMC, software, and cybersecurity standards is key to protecting both patients and users.
In this free webinar, DEKRA experts will guide you through the most relevant standards for IVD devices
✔ EMC testing for IVD equipment (EN/IEC 61326-1 & 61326-2-6)
✔ Electrical safety under EN/IEC 61010-1 and EN/IEC 61010-2-101
✔ Software lifecycle and security (EN/IEC 62304)
✔ The role of the EU AI Act in shaping IVD device requirements
Join us to gain practical insights into how testing supports safe product design and helps manufacturers meet regulatory expectations with confidence.
Hosted by
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Team member
Rafael Gonzalez dddd @ DekraRG T
Rafael brings over 30 years of expertise in CE marking and product certification. He’s a specialist in Electrical Safety and an active member of several technical committees.
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Team member
Omar Alejandro Deniz Amezcua Cybersecurity Technical SalesOD T
Cybersecurity Technical Sales professional at DEKRA Digital Trust Services. Former International Business professor at the University of Colima, with international experience in Mexico, Spain and South Korea. MBA from University of Malaga and Bachelor’s degree in International Business.
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External speaker
Alexis Ruiz Expert in AI for the Medical Sector @ DEKRAAR E
With a strong background in medical software development and regulatory compliance, Alexis is here to guide you through the latest in AI-enabled medical devices.
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Team member
Jose Manuel MárquezJM T
With over 15 years of experience, José is a seasoned pro in regulatory testing and certification. He’s here to help you understand the complexities of EMC and RF testing.
DEKRA
DEKRA is a global expert organization dedicated to safety, with over 48,000 employees in around 60 countries. They provide a wide range of independent expert services for safety in transportation, workplaces, and homes, including vehicle inspections, c...
