The Testing and Risk Management Impacts of Changing a Medical Device
Throughout its product life cycle, a medical device and its support system can undergo numerous changes—sometimes even...
Browse Content
PQ dose mapping and routine irradiation of products with non-uniform density distribution
Operational Qualification (OQ) dose mapping of gamma irradiators typically involves using homogeneous materials. However, the real-world scenario...
Best Practices When Validating Reusable Devices
The advancement of reusable medical devices has significantly transformed the medical device industry, bringing about changes in...
Impact of MDR on Biocompatibility, a Shortage of Expertise
As the deadline for the Medical Device Regulation (MDR) approaches, many medical device manufacturers are rushing to...
Cobalt-60: The Heart of Radiation Sterilization
For over 50 years, Cobalt-60 has served as a crucial source of gamma radiation, extensively used for...
Thermal Disinfection & Steam Sterilization Validation for Reusable Devices
Join hosts Jason Pope and Lise Vanderkelen in this informative webinar that will delve into the essential...
Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization
Medical device manufacturers using ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the...
Evaluating the biocompatibility of reusable medical devices during their whole life cycle
In the past, the primary focus for reusable medical devices was on validating reprocessing efficacy with regard...
The Production Process and Qualification of a Pharmaceutical Film
What is required to qualify primary packaging materials for Large Volume Parenterals (LVPs)? What factors should be...
Challenges and Considerations for Complex LVP Drug Products
Addressing the toxicological risks associated with patient exposure to leachables requires a strategy tailored to the unique...