Intro to Pre-Clinical Testing and Biocompatibility
In this episode of the RCA Podcast, host Brandon Miller is joined by Dr. Matthew Jorgensen and...
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Cytotoxicity Failure What Now
Cytotoxicity testing is a critical endpoint for all medical devices that come into contact with patients or...
Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
Flexible bag systems for large volume parenterals (LVPs) are subject to stringent regulatory oversight for extractables and...
Upcoming Changes to Cleaning Validations for Reusable Medical Devices
For the past decade, AAMI TIR30 has served as a key guidance document for the cleaning validations...
Assessing the Safety of Extractables and Leachables for Drug Products: When and How?
In this insightful webinar, Kevin Breesch of Nelson Labs will address the significant challenges associated with toxicological-safety...
Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices
Extractables and leachables (E&L) testing of combination devices requires a specific study setup that differentiates from a...
Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting
The submission process to the FDA can be a stressful and uncertain time for a medical device...
The Design and Qualification Process for a LVP Packaging System from a User Perspective
To meet the growing patient need for Large Volume Parenterals (LVP), increasingly complex packaging systems must be...
Bioburden Alert and Action Levels – Low Hanging Fruit for a FDA Citation
Most standards regarding bioburden and environmental testing emphasize the importance of establishing alert and action levels. These...
Design Change Impact on Biocompatibility and Documentation
Change management in the design of medical devices is a critical process, frequently highlighted in FDA 483...