Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices
Incorporating particulate testing into the development plans of medical devices, particularly cardiovascular devices, is crucial for ensuring...
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DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process
Reprocessing reusable medical devices involves cleaning, disinfecting, and sterilizing them to ensure they are safe and effective...
Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
Establishing Bioburden Alert and Action Levels
In the realm of bioburden, sterilization, and environmental testing, national and international standards play a crucial role...
Meeting the Requirements of 10.4 of MDR How to Address CMRs
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...
Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
Challenges in Design Development – Why Design Control Makes Sense
The journey from a novel idea for a new medical product to its commercial realization involves significant...
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Microbiological Control in a Pharmaceutical Manufacturing Environment
This webinar will focus on the evaluation of microbiological and environmental monitoring data, highlighting what constitutes significant...