What is Irritation and Sensitization
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley to delve...
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Lessons from the Lab
This eBook, created in partnership with Medical Products Outsourcing Magazine, addresses common challenges and best practices for...
Current Regulatory Acceptance of Alternative Testing for Biocompatibility
The release of ISO 10993-1 in 2018 marked a significant shift in the biocompatibility evaluation of medical...
FDA Regulation of Hand Sanitizers – What Testing Should be conducted to Markt a new Hand Sanitizer?
All hand sanitizers, whether used by consumers or healthcare professionals, are considered over-the-counter (OTC) drugs regulated by...
Disinfectant Efficacy Testing for Submission to the US Environmental Protection Agency
When developing a disinfectant or sanitizer (herein referred to as disinfectant) for use on environmental surfaces, the...
What is Changing in the Realm of Validations Regarding Reusable Devices?
Over the past decade, regulatory agencies have increasingly tightened requirements regarding reprocessing validations for reusable medical devices....
Changes in the Packaging Environment Relating to Regulations and Test Methods
In today’s complex and ever-changing world, packaging faces its own set of evolving challenges, particularly in light...
Updates to Med Device E & L What about Chemistry on Limited Contact Devices
Recent feedback from global regulatory bodies has increasingly emphasized the necessity of extractables and leachables (E&L) chemistry...
Biocompatibility Fundamentals for Medical Devices
This comprehensive eBook serves as an essential guide for professionals involved in the design and manufacture of...
Analytical Approaches used in E&L Studies from Basic Instrumentation to High-End, State-of-the-Art Equipment to Support Structural Elucidation
In this presentation at the 2022 Nelson Labs Virtual Symposium, attendees will be taken on a virtual...