MDSW WEBINAR SERIES
From Paper to Practice: Technical Documentation Essentials for Medical Device Software
Struggling to create MDR-compliant technical documentation for your Medical Device Software?
Join our webinar to gain practical insights on crafting essential technical documentation 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.
- OCTOBER 24, 2024
- 4-5 PM CEST
- EN
- MEDICAL DEVICES
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.
Speakers
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.