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

Struggling to create MDR-compliant technical documentation for your Medical Device Software (MDSW)?

On demand

Medical Devices

English

Watch now

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.

Speaker

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.

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

Agenda

Speaker

Caroline Aernouts

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