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...
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What is ISO13485
In this episode, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory...
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...
Tools of the Trade Ways to make EO Processing more Efficient
Ethylene Oxide (EO) sterilization is one of the most complex sterilization methods commonly used, with numerous approaches...
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...
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...
Radiation Sterilization Strategies for Improved Processing Options and Timing
In the current landscape of supply and material constraints, the increased popularity of radiation sterilization has led...
Medical Packaging and the Impact of NO2 Sterilization
Novel sterilization modalities are becoming increasingly prevalent in the healthcare industry, offering new solutions for ensuring the...
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...
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....