Partner content with ISACA. FDA studies have found that in the medical device industry, compliance alone is not enough to ensure improved quality indicators. Why? Because compliant medical-device manufacturers still report similar quality, complaint and performance issues as their uncompliant counterparts. “Part of the challenge is a cultural thing,” says Kim Kaplan, senior product manager […]
J&J
Johnson & Johnson MedTech’s participation in the Voluntary Improvement Program, supported by FDA
Vaccine panel postpones vote on J&J COVID-19 vaccine
A CDC advisory committee decided not to vote on how Johnson & Johnson’s COVID-19 vaccine should be deployed, reasoning that it needs more time to review data related to rare blood clots potentially linked to the vaccine. The CDC and FDA announced on April 13 their recommendation to pause the vaccine’s use on safety grounds. […]