news from fda Application of Human Factors Engineering Principles for Combination Products — Questions and Answers Guidance for Industry and FDA Staff. In September, 2023, FDA released their guidance ‘Application of Human Factors Engineering Principles for Combination Products: Questions and Answers’. This guidance finalizes the February 2016 draft version entitled ‘Human Factors Studies and Related […]
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?
Early product insights and fewer physical tests are some of the benefits of using Design of Experiments in medical device development.
Healthtech magazine article shines the spotlight on the challenges and rewards of building your business processes around regulatory compliance.
You have an idea for a new product. It is actually great and you think to yourself: ‘If I find this useful surely others will, too. People even say they can’t wait to get their hands on it.
Technolution’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.