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...
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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...
Calculation of the Duration of Exposure and Associated Biological Effects for Biocompatibility Evaluation
In the biocompatibility assessment of medical devices, two of the primary points of consideration are how long...
End-to-End Human Factors for Medical Devices and Reprocessing Usability Testing
Human factors engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and...