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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DHF and Design Control
In this episode, host Brandon Miller is joined by Jessica Schafersman, a Biomedical Engineer, Project Management Professional,...
Outsourcing and Staff Augmentation
In this episode, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates (RCA),...
The 3Rs of EO Sterilization – Sustaining the Continued Safe Use of EO
Ethylene Oxide (EO) sterilization technology is crucial for enabling critical medical products and devices to safely reach...
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...
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...