Pre-Conference Regulatory Workshop Day
Monday 27th January, 2025
7:45 am Registration & Networking
Workshop A: 8.30-10.30
Demonstrating In-Practice Strategies to Produce Regulatory-Grade Documentation to Increase Speed to Market
Synopsis
It is evident that producing regulatory-grade documentation is a challenge. What are some tools that are employed by companies to produce them more effectively? How can feedback loops be created to increase accuracy and efficiency from initial stages of software development?
- Working strategies shown through examples of documentation for AI based medical device software that will be raised as non-conformities if they are submitted to TUV SUD
- Ways to implement regular feedback loops to ensure process is kept in check
- Case study based showcasing regulatory clearances through these effective frameworks.
10:30 am Morning Break
Workshop B: 11.00-13.00
Ensure Seamless Traceability & Integration of Dependency Chains When Making Regulatory Alterations
Synopsis
Regulatory alterations will have a ripple effect on different components of the architecture. How can you more effectively employ tools to track and trace this process? How can you collate all dependency chains and ensure regulatory compliance is maintained before submission?
- Implementing automation tools to establish feedback loops throughout the software development process
- Challenges with providing complete traceability when making regulatory submissions
- Ensuring effective cross-functional collaboration to ensure periodic checks to make sure software is on-track for regulatory approval
1:00 pm Lunch
Workshop C: 14:00-16.00
Building Regulatory Documentation to Fulfil Requirements Across Multiple Regions of The World Through Early Internal Strategic Decisions
Synopsis
It is difficult to cater to local regulatory bodies, how can you produce documentation frameworks which can fulfil the different global regulations without using too many resources?
- Importance of initiating early conversations around strategies for regulatory submissions
- Aligning business goals with global regulatory guidelines to maximise effectiveness
- Establishing frameworks to collaborate effectively and accelerate international market entry