Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings

The quality and success of human factors validation projects have put a strain on key stakeholders since the FDA published guidance. Learn about a new study on the characteristics, practices, and critical success factors in this field. Findings are presented to inform an industry-focused project management maturity assessment tool.

Continue reading "Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings"

Developing an Industry-Focused Maturity Assessment Tool Based on Key Factors Critical to Quality and Success in FDA Human Factors Validation Projects – Overview

This work is Phase II of a research theme on the topic of human factors validation projects for medical devices and combination products. Initially, a review and analysis of the persisting concerns and also of the implications of failed FDA HF validation projects took place. One main problem delineated was that key stakeholders (namely procurers and […]

Continue reading "Developing an Industry-Focused Maturity Assessment Tool Based on Key Factors Critical to Quality and Success in FDA Human Factors Validation Projects – Overview"

A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool

As part of a comprehensive Quality System Regulation (QSR), the human factors (HF) validation requirement by the Food and Drug Administration (FDA) is a relatively recent topic. Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011. The scientific literature on the topic of ‘FDA HF validation requirement’ is mostly […]

Continue reading "A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool"

Auditing a Human Factors Validation Project with the SHF 2.0 Framework

During this assessment, you will evaluate the maturity level of your finished (or in progress) medical device human factors projects using our Maturity Model (SHF 2.0), which is based on best practices for successful human factors projects, within the context of medical devices that seek FDA approval. The purpose of this assessment is to help […]

Continue reading "Auditing a Human Factors Validation Project with the SHF 2.0 Framework"
Pioneering AI for Human Factors Engineering in MedTech with Suabix

AI-Enhanced Human Factors Excellence at Your Fingertips

Unlock the potential of human factors engineering for MedTech product success with groundbreaking AI tailored to your needs! Request FREE demo - Visit Suabix.ai

Don't Leave the Success of your Medical Human Factors & Usability Project to Chance...

Because when it comes to patient safety, success is the only option.

Subscribe

error: Content is copyrighted!!