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The Future of Biocompatibility Testing Might Just be Animal Free!
Cleaning Validation Roadmap for Reusable Medical Devices
Biocompatibility Evaluation for Device Submission
Strategies for Testing Hemocompatibility and Potential Upcoming Changes
Cleaning Validations for Reusable Medical Devices & FDA Test Trends
How to Use Biocompatibility to Evaluate Changes in a Medical Device
Satisfying ISO 18562 and FDA Biocompatibility Requirements for Breathing Gas Pathways Devices
If something looks clean, is it really clean? Cleaning validations for reusable devices
Evaluating the biocompatibility of reusable medical devices during their whole life cycle
Shortages of critical raw materials and managing changes and substitutions - Dennis Jenke
Addressing Common Observations in Regulatory Submissions of Chemical Characterization Results
Package Validations – Meeting the Requirements of ISO 11607
WISE Scientist Stories Megan Moffat
Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices
Developing Contamination Control Strategy
The need for a higher level of identifications in large volume parenteral packaging qualifications
The production process and qualification of film: A film manufacturer perspective
A Guide to Emergency Use Authorization of Gas Path Devices
Appropriate uses for Product Sterility Testing – when is sterility testing appropriate
Unknowns, TICs, and Identified Compounds Below the TTC