Case Studies
Improved Product Release Cycle Times, Improved Bottom Line
A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective to reduce the product release timeframe. However, they lacked internal...
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Case Studies
Risk Management in Product Development and Manufacturing
A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product lifecycle.
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Case Studies
FDA 483 Warning Letter Remediation
Background A Fortune 500 company received a Warning Letter from the FDA citing findings of device adulteration and misbranding, along with potential regulatory actions including product seizure, injunction, and civil...
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Case Studies
DHF Design History File Remediation
Background A large medical device manufacturer received a critical warning from its Notified Body: unless significant deficiencies in its Medical Device Directive (MDD) technical files were corrected promptly, the company’s...
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Case Studies
Medical Device Validation: Shelf Stability
Background A large medical products manufacturer encountered a critical issue during the development of a new blood collection device. Accelerated shelf-age validation testing revealed that the protective sheath surrounding the...
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Case Studies
Brand Name Re-Registration with New Logo
A medical device manufacturer was consolidating its product portfolio, leading to a product and logo change in 15 products distributed across 60 countries.
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