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...
Endotoxin Retention Testing for Filters
Bacterial endotoxins can negatively impact the quality and effectiveness of pharmaceutical products, medical devices, and other materials,...
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...
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...
2-part webinar: Navigating the 2025 ISO 10993-1 Revision + Challenges Encountered During ISO 10993-18 Testing & Possible Ways Out
Part 1 Navigating the 2025 ISO 10993-1 Revision ISO 10993‑1 is the standard that outlines the framework for the...
Human Factors Engineering for Medical Devices From Concept Through Reprocessing and Post-market Surveillance
Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to...
Reprocessing Implants: Challenges for Validation
Implant caddies or similar implant storage units for single use implants are commonly opened and exposed during...