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...
Browse Content
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...
Data Integrity in the Age of AI: Securing Connected Devices
As artificial intelligence becomes increasingly embedded in medical devices and healthcare systems, the concept of data integrity...
Reprocessing Implants: Challenges for Validation
Implant caddies or similar implant storage units for single use implants are commonly opened and exposed during...
Optimizing Ethylene Oxide Sterilization: Sustainable Solutions for Pharmaceutical Packaging and Drug Delivery Devices
Ethylene oxide (EO) remains the sterilization method of choice for approximately 50% of all single-use medical devices...
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...
Fundamentals of Disinfectant Efficacy
Disinfectants must be qualified on the surfaces present within a pharmaceutical manufacturing environment before they are approved...
