How to Make a Prototype in 4 Steps
Table of Contents After settling on a winning concept, prototype development is the next step in product development. In this phase, you will […]
Category: White Paper
Concept Development Guide: A Practical Framework for Product Teams
Concept development is the part of the product development process where you will generate, evaluate, and refine your abstract ideas, turning them […]
What Is Design for Manufacturing (DFM)?
DFM stands for Design for Manufacturing or Design for Manufacturability and is also sometimes referred to as DFMA, where the A represents […]
6 Things to Know About Human Factors Engineering of Medical Devices
Human factors engineering is a complex and multi-disciplinary area of risk management. It involves knowledge integration from various scientific fields, including psychology […]
Case Study: How to Reduce Prototype Cost with 3D Printing
The challenge The medical device market is historically fueled by innovation. The robotic surgical space is an area with a lot of […]
How to Design for 3D Printing
3D printing is a prototyping method that “prints” a three-dimensional physical object in layers from a digital file. Compared to traditional prototyping […]
How to Perform a DFMEA — Design Failure Mode and Effects Analysis
FMEA stands for Failure Mode and Effects Analysis and is a risk management tool for identifying potential failures. FMEA assesses the severity […]
What Is Biocompatibility? ISO 10993 Testing for Medical Devices
Biocompatibility testing is the best way to evaluate medical device safety. Through biocompatibility testing, the FDA confirms that either there are none […]
A Breakdown of the FDA’s Medical Device Record Requirements
Listed within the FDA’s 21 CFR 820 are detailed regulations governing medical device records and quality systems. These regulations identify five record […]
FDA 21 CFR Part 820 — Quality System Regulation for Medical Devices
21 CFR Part 820 is a set of FDA regulations that govern medical device quality systems. Detailed within are current good manufacturing practice […]