Future of Medical Devices: Leveraging AI & Adapting CDx Plan

Future of Medical Devices: Leveraging AI & Adapting CDx Plan
This event hosted by the TOPRA IN Scotland group will address Future Developments in Medical Device Regulatory Science - Leveraging Artificial Intelligence and Adapting to the Expectations of IVDR for your CDx.






Date: Wednesday 5 March 2025
Time: 14:00 - 17:00 GMT 


Registration is open for TOPRA in Scotland's first meeting of 2025, which will  be held at the Medical Device Manufacturing Centre (MDMC).  Join us to discuss the future of medical device regulatory science with our expert presenters.  Presentations will include:

Performance Evaluation for Companion Diagnostics (CDx) under Regulation (EU) 2017/746 (IVDR) – an overview

Under the Directive 98/79/EC (IVDD) companion diagnostics (CDx) were regulated as ‘general’ in vitro diagnostic devices. Adoption of the Regulation (EU) 2017/746 (IVDR) has resulted in a change to the conformity assessment procedure with all companion diagnostics being classified as Class C (the second highest risk level), which involves mandatory involvement of a Notified Body with the requirement for review of the technical documentation dossier, including a performance  evaluation documentation component. 

The presentation shall cover a summary of the performance evaluation documentation package required for Notified Body submission including:

    · Performance Evaluation Plan (PEP)
    · Scientific Validity Report (SVR)
    · Analytical Performance Report (APR)
    · Clinical Performance Study Plan (CPSP)
    · Clinical Performance Study Report (CPSR)
    · Clinical Performance Report (CPR)
    · Performance Evaluation Report (PER)

Product Development - What's AI Got To Do With It? 

Artificial Intelligence (AI) is transforming the landscape in healthcare.  In MedTech, AI-driven tools are redefining diagnostics, treatment planning, and patient care. In the Biotech sector, AI is accelerating research and development by streamlining drug discovery, optimizing gene editing, and advancing synthetic biology. These emerging technologies are transforming the regulatory landscape rapidly and it is important for manufacturers to fully understand the regulatory requirements. 
 
The presentation shall cover a summary of how artificial intelligence can play a role as part of the medical device or as a tool in the product development lifecycle:

    · Overview of Cloud System
    · AI Tools + Examples + Regulatory Requirements
    · AI Med Devices + Examples + Regulatory Requirements
    · Data Management and Model Validation
    · Link to Cybersecurity + Data Privacy
    · Application of the Risk Management Process
    · Comparing US and EU regulatory landscape for AI

Speakers

Shona Dunlop, Senior Consultant, CS Lifesciences. Shona Dunlop is a Senior Consultant within CS Lifesciences. She has more than 15 years regulatory experience and has worked with all classes of in vitro diagnostic (IVD) and medical devices including companion diagnostics, point-of-care tests, implantable medical devices, including drug-device combination products, custom-made devices and those incorporating animal tissue.

Hima Chetty, Principal Consultant, CS Lifesciences.  Hima Chetty is a Principal Consultant with CS Lifesciences with 14 Years of experience in Medtech focussed on testing to safety standards, preparing regulatory submissions, global market-access strategies, risk management, usability studies, and design and development (Hardware, Software and Artificial intelligence).

May Lee, Senior Consultant, CS Lifesciences.  May Lee is a Senior Consultant with CS Lifesciences with 10 years of Medtech experience. She has worked on regulatory submissions for all classifications of medical devices, with a focus on software development and artificial intelligence policy and regulations.
 

Pricing
Member Free
Non-member £45
When
05/03/2025 14:00 - 17:00
Where
Medical Device Manufacturing Centre Lumsden Suite, Edinburgh Business School Heriot Watt University, Riccarton Campus Edinburgh EH14 4AS UNITED KINGDOM
Sign in or create an account to register Registration ends 04/03/2025 17:00 (GMT Standard Time)
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