How to Avoid Chemical Characterization Pitfalls in Medical Devices
Medical device chemical characterization testing per ISO 10993-18 is often the leading source of delay, cost overrun,...
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Beyond LAL: The Future of Endotoxin Testing Is Recombinant
Bacterial endotoxins can negatively impact the quality and effectiveness of pharmaceutical products, medical devices, and other materials....
What does risk-based biocompatibility under the new ISO 10993-1 really look like?
The era of the "checklist" approach to biocompatibility is officially over. With the publication of ISO 10993-1:2018...
Growing Supply: Cobalt-60 Production in the United States
Cobalt-60 is a vital radioisotope used in a variety of applications, notably the sterilization of over 16...
Endotoxin Retention Testing for Filters
Bacterial endotoxins can negatively impact the quality and effectiveness of pharmaceutical products, medical devices, and other materials,...
Always Inspection Ready: Mastering FDA Inspection Preparation and Response
With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This...
Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change
A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch...
Expanding Your Pharmaceutical QMS for Combination Product Success
As combination products, such as prefilled syringes, auto-injectors, and drug-device kits, become more prevalent, pharmaceutical and biologic...
Ensuring Drug–Device Compatibility: Foundations for Safe and Effective Combination Products
As combination products continue to advance healthcare, ensuring compatibility between drug formulations and device components is essential...
Reprocessing Rethought: Mastering the Worst-Case Soil Challenge
To perform cleaning validations according to ANSI/AAMI ST98:2022, the intended use and clinical conditions of medical devices...