Module 12 2019

Questions for RA to answer

1. What to do with all the data?

2. Can we “trust” the data?

3. What areas of ML/AI do we focus on?

4. Will “everyone” buy into this?

5. How can we leverage what we have done in the past?

6. Is this the FDA’s Digital Health Software Precertification ( Pre-Cert ) Program a model for the future?

7. What will happen if we don’t adopt ML/AI???

The Organisation for Professionals in Regulatory Affairs

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