Gamma: the heart of radiation sterilization past, present and future
The COVID-19 pandemic of 2020 highlighted the pivotal role of the medical device supply chain in delivering...
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Microbiological Control in a Pharmaceutical Manufacturing Environment
This webinar will focus on the evaluation of microbiological and environmental monitoring data, highlighting what constitutes significant...
Considerations for Third Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by third-party reprocessors can enable healthcare providers to maintain...
MPO Packaging Validations – A Look at Current and Future State Testing
This webinar will explore the significant changes implemented with the release of the Medical Device Regulation (MDR)...
Guidance for Cleaning, Disinfection and Sterilization of Reusable Medical Devices
All reusable medical devices must include specific instructions for cleaning, disinfecting, and/or sterilization to ensure patient safety...
Outsourcing Surveillance Activities
In this episode, host Erika Porcelli is joined by Steve Cox, a Senior Consultant at Regulatory Compliance...
Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
The final draft revision of part 18 of the ISO 10993 series, now titled “Chemical Characterization of...
Navigating Packaging Changes in Light of New Regulatory Requirements
With the deadline for implementing the new Medical Device Regulation (MDR) fast approaching, it is crucial for...
Biocompatibility and the New MDR
This presentation will provide an in-depth overview of biocompatibility in compliance with the new Medical Device Regulations...
Data Integrity and Quality Culture
In this episode, host Erika Porcelli is joined by Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates...