AI in Medical Devices: Applicable Guidance to Prepare for MDR Conformity Assessment

Artificial Intelligence (AI) is rapidly transforming the healthcare and medical device industries by enabling enhanced diagnostics, decision support systems, and patient outcomes. However, the use of AI in medical devices introduces unique regulatory, performance, and safety challenges. This webinar focuses on providing professionals in the medical device sector with a practical assessment checklist for evaluating AI software, ensuring safety, security, and compliance with international standards. 

*NOTE: Please note that webinar is conducted for knowledge-sharing purpose, hence please avoid making this a sales pitch. 

Importance of the topic: 

With the increasing integration of AI into medical software and devices, regulatory bodies such as the FDA, EU MDR, and other global authorities are setting clearer expectations for risk management, transparency, and accountability. Failure to meet these requirements can delay approvals and compromise patient safety. This webinar helps participants understand what to look for when assessing AI in this highly regulated environment. 

To view the webinar, fill up the form now.

OUR WEBINAR WILL TACKLE THESE POINTS, FOCUSING ON:

• Overview of regulatory expectations for AI-based medical devices
• Key elements of an AI software assessment checklist
• Aligning the AI software lifecycle with international standards
• Common pitfalls in AI software validation and how to avoid them

Who should attend this webinar: 

• Quality Assurance Professionals 
• Medical Device Manufacturers and Developers 
• Clinical Evaluation and Risk Management Teams 
• R&D and AI/ML Engineers working on healthcare solutions 
• Compliance Officers and Product Managers in MedTech 

About THE SPEAKER