On Demand Webinar

From Paper to Practice: Technical Documentation Essentials for Medical Device Software

Watch our webinar to gain practical insights on crafting essential technical documentation (TD) with confidence.

Medical Devices

On Demand

60 min

Regulatory Affairs · Medical Devices

English

nce.

We’ll take you step-by-step through interpreting MDR requirements, choosing the right accredited Notified Body, and navigating the qualification and classification process—all with a focus on your software’s Intended Purpose.

Don’t miss this opportunity to ensure your documentation is not just compliant, but also clear and comprehensive.

What you'll learn

Practical guidance for creating comprehensive TD for MDSW.
Interpret MDR for MDSW and navigate its unique requirements.
Types of software documentation needed in TD.
Implement MDR-compliant SOPs in your QMS.
Best practices for setting up UDI requirements.
Manage post-market surveillance for MDSW.
Handle software releases and notify Notified Bodies effectively.

Learn from the best

Speakers

Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.

Caroline Aernouts

Senior Consultant RA MD

With 3 years at the QbD Group as a consultant in Regulatory Affairs for medical devices, Caroline’s main expertise lies in Medical Devise Software (MDSW). Before this, she spent 5 years at Materialise, focusing on MDSW and CM implants.

Keep watching

More webinars

On Demand Webinar

Entering the European MedTech Market: Why One Approval Doesn't Fit All

Regulatory AffairsMar 3, 2026

Building on QbD Group's Landing in Europe MedTech whitepaper, this webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, Notified Body interactions, and lifecycle obligations.

Watch now

On Demand Webinar

From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software

Regulatory AffairsDec 24, 2024

This webinar will guide you through the essential steps of market access, effective commercialization strategies, and all the critical factors needed for a successful MDSW product launch. Whether you’re a seasoned professional or new to the field, this session will provide you with the knowledge and tools to make your MDSW vision a reality.

Watch now

On Demand Webinar

Drug-Device Combination Products and Article 117

Regulatory AffairsDec 17, 2024

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.

Watch now