Trying to ensure a smooth path through the US Food and Drug Administration for your device or combination product? Don’t forget to factor in human factors, Rita Lin, director of human factors engineering at consulting firm Agilis by Kymanox, said on 4 October at RAPS Convergence in Montreal.
Former FDA Reviewer Explains ‘Factoring’ For Human Factors At RAPS
At RAPS Convergence in Montreal, former FDA reviewer Rita Lin discussed the ways the agency wants to see developers consider human factors.
More from Regulation
• By
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
• By
About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
• By
Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.
More from Conferences
• By
Medtech Insight sat down with Intuitive Surgical CEO Gary Guthart at the recent LSI USA conference to discuss the full launch of the new da Vinci 5 robotic system and planned digital enhancements. Guthart also offered his views on health care interoperability, AI regulation, outpatient surgeries, autonomous robots, and how the company is harnessing technology to shape the future of robotic surgery.
• By
The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.
• By
Medtech Insight sat down with Anja Streicher, chief marketing officer at Women of Wearables, a global community offering events and education resources to support the femtech industry, to discuss trends in the women's wearables tech market, challenges and innovators pushing the boundaries.