End-to-End Human Factors for Medical Devices and Reprocessing Usability Testing
Human factors engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and...
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Navigating the FDA’s Medical Device Pre-submission Process
This presentation provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for...
DHF and Design Control
In this episode, host Brandon Miller is joined by Jessica Schafersman, a Biomedical Engineer, Project Management Professional,...
What is Irritation and Sensitization
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley to delve...
Outsourcing and Staff Augmentation
In this episode, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates (RCA),...
What is ISO13485
In this episode, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory...
FDA Medical Device Inspections in the Post Pandemic World
The FDA is ramping up its inspections of medical device manufacturing facilities. Are you ready? Since March...
What is Cytotoxicity
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel. Dr....
Intro to Pre-Clinical Testing and Biocompatibility
In this episode of the RCA Podcast, host Brandon Miller is joined by Dr. Matthew Jorgensen and...
Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success
In this webinar, Susan Schniepp, distinguished fellow at Regulatory Compliance Associates®, will delve into effective approaches for...