Always Inspection Ready: Mastering FDA Inspection Preparation and Response
With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This...
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Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change
A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch...
Expanding Your Pharmaceutical QMS for Combination Product Success
As combination products, such as prefilled syringes, auto-injectors, and drug-device kits, become more prevalent, pharmaceutical and biologic...
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...
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),...