Medical Device Regulation – Regulatory Frameworks & SFDA Updates

Speaker Biography

Richard Tully is a medical device regulatory leader with 15+ years of global experience, including serving as Special Advisor on Medical Devices to the Saudi FDA and supporting compliance across the EU, UK, and Africa.

Outlines:

• Format and scope of medical device regulations
• Device recognition principles
• Software as a Medical Device (SaMD)
• Requirements for economic operators
• Medical device classification