Single Use Endoscopes Critical Safety and Regulatoy Considerations for Manufacturers
The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of...
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The Impact of Sterilization Modality on Connected Devices with Electronic Components
devices. The complex nature of connected devices, which often involve a combination of materials and electronic components, can...
The Transfer of Medical Device and Pharmaceutical Products between Radiation Sterilization Modalities
With the growing demand for sterilization of medical devices and pharmaceutical products, the industry is increasingly looking...
The Impact of Radiation Sterilization Modalities on Flexible Sterile Barrier Packaging
Selecting the appropriate sterilization technology for your product and organization involves numerous factors. In this informative webinar,...
Understanding Container Closure Integrity Test Failures
Does a container closure integrity test (CCIT) failure always indicate a defective closure? This webinar aims to...
Reprocessing Validations Flexible Endoscopes and AAMI ST91
The newly revised AAMI ST91:2021 standard provides comprehensive guidelines for the processing of flexible and semi-rigid endoscopes...
Outsourcing and Staff Augmentation
In this episode, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates (RCA),...
What is ISO13485
In this episode, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory...
Biocompatibility Fundamentals for Medical Devices
This comprehensive eBook serves as an essential guide for professionals involved in the design and manufacture of...
The Necessity of Extractables and Leachables Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.
When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), a fundamental question arises: How...