The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a...
Matthew Ward
Integration of Human Factors Engineering with Design Controls
Our Sr. Quality Engineer Matt Ward explains how to build a strong Design History File for your product by incorporating human factors engineering into the design controls and risk management plan for your product. Learn how risks can be mitigated in the early stages of product development by integrating HFE into the design of your product.
Storage and Distribution Controls of Medical Devices
Are you working with a product whose fitness for use or quality deteriorates over time? Does your Quality Management...
Use of 3D Printing in the Manufacturing of Medical Devices
Does your Quality Management System support using a 3D printing process to manufacture a medical device or a component...
Human Factors & Usability Engineering in Medical Devices
Does a Human Factors/Usability Engineering (HFE) validation study need to be completed for your medical device? ...
Integration of Usability / Human Factors Engineering into a Risk Management Process
Does your medical device Risk Management process include Usability / Human Factors Engineering (HFE)? For many...
Application of Risk Management to Medical Devices in the EU
For medical devices, ISO (International Organization for Standardization) is one of the most significant...
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