The agency seeks to balance expedient exemptions against public transparency about medical devices
European MDR update: Lowest risk medical devices must comply by May 26, 2020
Three-quarters of life sciences CIOs and IT execs say security risks are main reason for opposing cloud technologies
Setting up for long-term success
Questions linger about FDA processes that seem to favor medical device companies
Confronting the fear of being displaced by machines
The velocity at which digital transformation is reshaping business models seems utterly chaotic in a compliance-based industry
Huge amounts of biometric, DNA, and diagnostic data enable personalized medicine. They also enable unscrupulous and discriminatory marketing.
A cloud-based QMS can help address common international standards and regulations
Particularly in regulated industries, you really do want to know what goes into the sausage
A primer for life science manufacturers
A timeline of FDA and Sparta System activities
Easing regulatory compliance
A concise history of FDA’s risk-based Site Selection Model
What can we learn from the organizational cultures of different industries?
In this episode: China trade and a demo of web-based management system software
Three great guests
ISO vs. FDA audits, Baldrige winners, and what we can learn from GE
How BioBridge Global leverages a digital QMS in the heavily regulated world of regenerative medicines
From digital submissions to integrated document control, the agency moves into the lean arena
