Principles for Combination Products: Questions and Answers Guidance for Industry and FDA Staff 

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 […]

Design Control as a discipline

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.

A checklist for better product requirements

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.