Masterclass - The regulation of DTx

Regulation is an absolute essential for DTx companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your DTx product through regulatory pathways in the USA and EU? Join us in this Masterclass led by BlueBridge Technologies to learn more about:

• The evolution of the US and EU regulatory regimes for SaMD: Key similarities and differences between regimes MDR, FDA Pre-Cert program, MDSAP
• What should DTx companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?
• FDA Digital Health Center of Excellence (DHCoE): focus and roadmap
• Changes expected in the US and EU regulatory regimes for SaMD in the next 2 years