Validation Studies
Validation or summative studies are an important milestone in a medical device or combination product development. Good study preparation and planning will ensure that there are no delays to your final submission. We will work closely with you to make sure that you are ready to carry out your validation study and have the best possible chance of success.
All our studies are carried out in accordance with FDA Human Factors guidance and ISO 62366-1:2015. If you are planning on getting approval by the FDA, your Human Factors validation study must be conducted in the USA with the target user population, with a minimum of 15 participants per distinct group.
We are experts in:
• Overall validation study strategy
• Support with protocol reviews from regulatory bodies
• Identification of user groups and training plans for the study
• Identification of critical tasks for validation testing
• Protocol design, discussion guide, pass/fail/near miss criteria
• Working with external agencies to recruit target population
• Clear root cause analysis for summary reports
• Moderation and observation of the study
• Analysis and report writing
• Support with Human Factors Summary Reports and final submission
We are experts in:
• Overall validation study strategy
• Support with protocol reviews from regulatory bodies
• Identification of user groups and training plans for the study
• Identification of critical tasks for validation testing
• Protocol design, discussion guide, pass/fail/near miss criteria
• Working with external agencies to recruit target population
• Clear root cause analysis for summary reports
• Moderation and observation of the study
• Analysis and report writing
• Support with Human Factors Summary Reports and final submission
