Demonstrating In-Practice Strategies to Produce Regulatory-Grade Documentation to Increase Speed to Market
Time: 8:30 am
day: Pre-Conference Regulatory Workshop Day
Details:
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.
