Quality Management Insights for Medical Device Manufacturers
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The Center for Devices and Radiological Health (CDRH) puts a premium on quality for medical devices
Solving Compliance and International Manufacturing Challenges
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Satisfying compliance to FDA regulations and client demand is greatly simplified with up-to-date technology
Sponsored Content
PRISM Identifies Vaccine Safety Issues
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PRISM is a computer-based vaccine safety monitoring system that sifts out critical information
FDA: Helping Small Businesses Get Big Results
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Small companies have a significant impact on U.S. made pharmaceuticals
It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.
Five Tips for Medical Device Engineers on FDA Design Controls
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Design controls are a necessary part of your requirements as a medical device developer.
Opening the FDA’s History Vault
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The FDA curates a collection of deceptive and dangerous foods, medicines, and so-called medical products.
Tougher Quality Management Enforcement Possible by FDA
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The FDA will have more funding to do its job—including more inspections of life sciences manufacturers
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
Key Challenges for Risk Management in Medical Device Development
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Risk management is a full life-cycle activity for medical device development
