Best of „AI CE marking“

Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the entire product lifecycle.

In two podcast episodes featuring Sandy Wright and Osman El-Koubani, we explore the journey from certifying LLM-driven medical devices to managing them after CE marking.

Certifying LLM-Driven Medical Devices

Large Language Models such as ChatGPT, Gemini, and Claude introduce new regulatory challenges. Unlike traditional software, these systems raise questions around predictability, validation, traceability, supplier management, and model updates.

Topics discussed include:

• What defines an LLM-driven medical device
• Clinical evaluation strategies
• Demonstrating clinical benefit
• Using commercial AI models
• Supplier controls and external dependencies
• Significant changes and model updates

Life After CE Marking

Obtaining CE certification is not the end of the journey.

AI medical devices require continuous monitoring once they reach the market.

Manufacturers must address:

• Performance drift in real-world settings
• Collection and analysis of real-world data
• AI retraining and change management
• Predetermined Change Control Plans (PCCPs)
• Post-Market Surveillance (PMS)
• Continuous safety and performance evaluation

AI Devices Require a Lifecycle Approach

AI systems are dynamic technologies. Success depends not only on achieving certification, but also on maintaining control over performance, updates, and clinical safety throughout the product lifecycle.

As regulations continue to evolve, manufacturers must combine robust development practices with proactive post-market monitoring to ensure long-term compliance and patient safety.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com

 If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.

Link

• Sandy LinkedIn: https://www.linkedin.com/in/wrightsandy/
• Osman Linkedin: https://www.linkedin.com/in/osman-kan/
• Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

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