Data Integrity in the Age of AI: Securing Connected Devices
As artificial intelligence becomes increasingly embedded in medical devices and healthcare systems, the concept of data integrity...
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Human Factors Engineering for Medical Devices From Concept Through Reprocessing and Post-market Surveillance
Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to...
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...
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...
What is Irritation and Sensitization
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley to delve...
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),...
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....