Biocompatibility Essentials
Biocompatibility is a crucial aspect of medical device design and manufacturing, ensuring that devices do not cause...
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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...
Virucidal Efficacy Testing for Submission to Regulatory Agencies
Virucidal efficacy testing is essential for determining the effectiveness of disinfectants or antiseptic products against viruses. This...
Big Changes to ISO 10993 What is happening to the main biocompatibility standard now?
In 2018, TC194, the ISO committee responsible for biocompatibility, released a new version of the 10993-1 standard....
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...