Device Giants Stryker And Baxter Embrace A ‘Quality First’ Culture – And Yield Positive Results
From cutting costs to getting products to market faster, experts at the two companies explain why it pays to keep quality at the fore.
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10 Things You Need To Know About FDA’s Proposed Quality Management System Regulation
Longtime industry experts Kim Trautman and Eric Henry highlight some of the more important takeaways from the US FDA’s draft rule that would create a new Quality Management System Regulation, or QMSR, to replace its current Quality System Regulation.
Success Of Case For Quality Program Triggers ‘Culture Shift’ At FDA's Device Center, Officials Say
The US FDA’s Cisco Vicenty and Bleta Vuniqi say the Case for Quality Voluntary Improvement Program has shifted the culture at the agency’s Center for Devices and Radiological Health. That shift is “starting to … feed and percolate into other areas and other activities that the center’s been engaged in,” Vicenty says.
Leadership Engagement Playbook Gives 10 Best Practices To Cultivate Quality Culture
The new playbook from the Case for Quality Collaborative Community aims to shift the mindset of device manufacturers from one of regulatory compliance to one of organization-wide quality.