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Medical Devices: Case Studies
It’s never good when a new product is just weeks from introduction and shelf stability becomes a liability. read more
- Technical File Remediation
A large medical device company was warned that their ISO certification would be withdrawn unless serious inadequacies in the technical files supporting their products were addressed in timely manner. read more
- FDA Warning Letter Remediation
The FDA determined that the responses of a Fortune 500 company to certain observations on an FDA 483 were inadequate. read more
A manufacturer of medical devices designed and built automation equipment to assemble and weld medical grade check valves. read more
- Process Validation Remediation
A large global medical device manufacturer received a warning letter from the FDA as a result of repeat 483 observations for process validation deficiencies. read more
- Product Cleaning Endotoxin Control
A medical device manufacturer was experiencing occurrences of unacceptable endotoxin levels on finished, cleaned surgical needles. read more
- Regulatory 510(k) Analysis Development Product Cleaning/Disinfection
A global Fortune 500 company wanted to eliminate pre-sterilization by ethylene oxide (EtO) of a family of medical devices. read more |
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