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Artificial intelligence (AI) Regulatory Guidelines And Their Impact On MDR Technical Documentation
Pre-requirement:
Intermediate (acquired knowledge of MDR TD basics)
- What is currently existing on AI guidelines
- MDR chapters implications
- EU versus rest of world (RoW)
- All applicable standards
Overview of the webinar
Taking the AI act, ISO standard and AI guidelines from the notified bodies and understand its impact on the writing of the technical documentation.
We will dive deeper into the practicalities of the AI act on medical devices and the MDR.
Next to this, we take a look at the ISO standard on AI and the guidelines on AI, created by the notified bodies. We will go step by step over the technical documentation MDR chapters and see where the regulatory guidelines cause additional work, and what kind and the amount of work that needs to be done.
Thirdly, a quick overview of where EU MDR differentiates with other regions in the world (US for example).
Lastly, we give a complete overview of the existing standards related to AI.
Who should attend?
- Regulatory Affairs
- Quality Assurance & Regualatory Affairs
- Project Managers
Why should you attend?
To understand the impact of the AI act, the ISO standards on AI, the existing guidelines on AI how to approach the MDR in general and the technical documentation specific.
Faculty - Ms.Caroline Aernouts
Caroline Aernouts, has 16 years of experience and 6 years in regulatory affairs. Graduated in 2008 as dietician/ food scientist (Plantijn Hogeschool Antwerpen). Caroline started her career as QA/ QC Assistant and Manager in the Food Industry, at Delhaize, Cargill and Perfetti Van Melle (Frisk in Belgium). After 8 years, she shifted from the food industry towards the Medical Device industry at Materialise. At Materialise, Caroline moved from QA to Regulatory Affairs working on 3D printed implants and pre-planning software as medical device.
To eventually start in 2022 at QbD Group as Regulatory Affairs Expert for Medical Devices and her field of expertise are mainly 3D printed, custom-made devices specific and orthopaedic devices in general, medical device software and software applications within the EU MDR.