IVDR Workshop
Make your software IVDR-ready with confidence
Understand, prepare for, and implement IVDR requirements in your development process
This workshop offers a hands-on, deep dive into the regulatory, technical, and usability aspects of IVDR as it relates to software.
You’ll learn what qualifies as IVD software, how to classify it, and how to build documentation, quality systems, and traceability frameworks that support compliance.
We’ll also cover practical aspects of system design, cybersecurity, and usability, based on ISO and IEC standards like 62304, 13485, and 14971.
What you will learn
What qualifies as IVD software under IVDR
Risk classification, conformity assessments, and documentation planning
Quality management and risk management requirements
How to structure traceability and design documentation
Usability, data integrity, and cybersecurity expectations
What to expect from notified bodies and how to prepare
Who should attend?
Software teams developing diagnostics tools
IVD and MedTech companies
Product managers and tech leads
Companies targeting regulated IVD market
Delivered by
BioSistemika team of senior software engineers, regulatory specialists, and project leads with hands-on experience in IVDR-compliant systems development.
BONUS: Participants receive a complete guide to IVDR software requirements, covering classification, conformity assessment, software expectations, and key standards like ISO 13485, ISO 14971, and IEC 62304.
This guide is designed to support your internal teams with structured knowledge and actionable next steps.
Let’s talk about your team’s training needs
Contact us to plan an internal session for your company.
