How an FDA Pre-submission Enhances Your Usability Engineering Process
Discover the advantages of incorporating FDA pre-submission insights into your usability engineering process for streamlined success.
Want to know the latest in Pharma, Diagnostics and MedTech manufacturing? Explore our latest insights below.
Discover the advantages of incorporating FDA pre-submission insights into your usability engineering process for streamlined success.
It’s not just about having a great idea but also about balancing desirability, feasibility and viability.
In this article, we’ll explore why imagination is just as important as analytics when it comes to driving innovation.
News from fda Application of Human Factors Engineering Principles for Combination Products — Questions and Answers
This article will introduce you to assessing the usability impact of your design change and thereby plan for any needed summative evaluation.
Find out how you can identify use errors and their sources and get valuable design input with PCA analysis.
Will a medical device break apart when dropped onto a concrete floor? Does the device remain safe and functional if stored for years on a shelf before reaching the patient?
Will a medical device break apart when dropped onto a concrete floor? Does the device remain safe and functional if stored for years on a shelf before reaching the patient?
Healthtech magazine article shines the spotlight on the challenges and rewards of building your business processes around regulatory compliance.
Will a medical device break apart when dropped onto a concrete floor? Does the device remain safe and functional if stored for years on a shelf before reaching the patient?
MGS Design & Development's design control specialists can quickly gain an overview of the product and the project to ensure a red thread during the design control documentation process.
Too many projects stall out or fail due to ambiguous or unspecific design input requirements. We give you a checklist for writing requirements that won’t be misinterpreted.
What you need to know about the updates to the 2019 version of ISO 14971.
Make the Risk Management process work for you with a few tips for smarter documents and procedures.