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...
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What Makes a Great Quality Management System
In this episode, guest host Dean Coston is joined by Susan Schniepp, Regulatory Compliance Associates Inc.’s (RCA)...
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...
Design of Protocols for Biologics
In this episode, host Brandon Miller is joined by Steve Lynn, Executive VP of Pharmaceuticals, and Walter...
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...
On Site Inspections: They’re Back – But When, Where and How
With the development and distribution of COVID-19 vaccines, the global health crisis is beginning to ease in...
Cleaning, Disinfection and Sterilization of Medical Devices: Updates to Reprocessing Guidance Documents AAMI TIR 12 and TIR30 (ST98)
The cleaning, disinfection, and sterilization of medical devices are critical processes that ensure patient safety and device...
After E&L Updates to the Standard for Toxicological Risk Assessment 10993-17
The use of extractables and leachables (E&L) chemistry testing has become integral and often essential in the...
Cytotoxic Reactivity Understanding the Cause and the Path Forward
All medical devices intended to contact patients must undergo a rigorous biological evaluation to ensure their safety....