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. 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.

Medical Devices

On Demand

60 min

Regulatory Affairs · Medical Devices

English

r 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.

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