Services

Summary

Training your team to be proficient in human factors engineering processes, best practices, and regulatory expectations.

​

​What's included

• Two back-to-back days of training (4 hours each). 

• Training materials (slide deck)

​

Time

2 business days

​

Pricing

$8,000​​​​​​​​​​​​​

Summary

Review your entire human factors/usability engineering file to ensure compliance with regulatory expectations so you can submit (e.g. 510k, IDE, PMA) with confidence.

​

What's included

• Review of summative protocol, relevant use-related risk documents, instructions for use, summative report, and HF/UE summary report

• Identification of red flags and compliance gaps

• Prioritized actionable recommendations aligned with FDA Human Factors Guidance/IEC 62366 AAMI HE75

​

Time

7 business days

​

Pricing

$6,000

​

Summary

Review your summative documentation so you can complete your summative with confidence.

 

What's included

• Review of one summative protocol, relevant use-related risk documents, instructions for use

• Identification of red flags and compliance gaps

• Actionable recommendations aligned with FDA Human Factors Guidance/IEC 62366/AAMI HE75

​

Time

5 business days

​

Pricing

$4,000

Summary

Follow up review of documentation that you've fixed.

 

Who it's for

Med device teams who've made adjustments based on recommendations and want confidence they're now meeting regulatory expectations.

 

What's included

One round of review Ensures your updates fully align with recommendations and regulatory expectations

 

Time

3 business days

 

Pricing

$500