Episode 16 - FDA Relaxes Regulation
This episode's guests: Richard Morroney
This episode we are talking with Richard Morroney, Director of Regulatory Compliance at Inspirata.
The global COVID-19 public health emergency brought about many changes including a relaxation of FDA regulation of slide scanners and displays in digital pathology.
A notice was recently placed in the Federal Register by the FDA ,through Health and Human Services, soliciting a 90-day comment period to discuss permanently waving FDA regulation over certain medical devices. We will be discussing the significance of these possible changes with Richard Morroney, Director of Regulatory Compliance at Inspirata.
More About Richard Morroney
Richard Morroney, Director of Regulatory Compliance at Inspirata.
Richard Morroney has been the Director of Regulatory Compliance at Inspirata since 2015 and is responsible for enforcement of global compliance regulations for Inspirata’s solution offerings. He has more than 20 years of experience in manufacturing operations, international regulatory affairs, quality systems, risk management, clinical development and regulatory compliance within the aerospace and medical device industry. With this experience comes the successful execution of market clearances of medical software in Brazil, Mexico, South Korea, China, Japan, Taiwan, Singapore, Australia, Canada and the U.S.