Usability & Human Factors Testing
Evaluation of your usability engineering process and file to IEC 60601-1-6 and IEC 62366-1, with an ASCA summary test report for your FDA 510(k).
- IEC 60601-1-6
- IEC 62366-1
- FDA human factors guidance
Why Sigma
Usability evidence FDA reviewers recognize
We check that your usability engineering process is complete, traceable and tied to your risk management, so the evidence holds up in review.
- FDA ASCA-accredited for IEC 60601-1-6: your report comes with an ASCA summary test report for the 510(k).
- Clause by clause against IEC 62366-1: use specification, user interface, hazard-related use scenarios and evaluation records.
- Linked to risk management: we check that use errors trace to your ISO 14971 hazards and risk controls.
- One program with IEC 60601-1: usability is evaluated together with electrical safety and the other collateral standards.
What we evaluate
Every part of your usability engineering file
Reviewed for completeness, traceability and consistency with your risk management file. See how we measure →
Standards we test to
Standards and accreditation status
Each result is reported under the accreditation that covers it.
| Standard | Scope | Accreditation |
|---|---|---|
| IEC 60601-1-6 | Collateral standard: usability of medical electrical equipment | ASCA · A2LA |
| IEC 62366-1 | Application of usability engineering to medical devices, as required by IEC 60601-1-6 | Via IEC 60601-1-6 |
| FDA guidance (February 3, 2016) | Applying human factors and usability engineering to medical devices | Followed |
| ISO 14971 | Risk management: use-related hazards and risk controls | Referenced |
Don’t see your standard? Contact us; we will tell you whether we can test to it and how it would be reported.
When you need it
From first submission to post-market
Support across the product life cycle, for new devices and for changes to cleared ones.
Your challenges, our solutions
What manufacturers ask us most
“Our usability file was written after the design was finished.”
We show you what is missing so the file traces use scenarios to risk controls and design decisions.
“Which tasks belong in the summative test?”
We review your hazard-related use scenarios and critical tasks before you recruit participants.
“FDA asked for human factors data.”
We help you scope the human factors evidence and present it the way the FDA guidance expects.
Your test report
A report ready to file
Clause-by-clause verdicts with the evidence from your usability engineering file.
- Clause-by-clause verdicts for IEC 60601-1-6 and IEC 62366-1
- Review of the use specification and user interface specification
- Traceability from use errors to hazards and risk controls
- Assessment of formative and summative evaluation records
- Findings and gaps, with the clause and evidence
- ASCA summary test report (within ASCA scope)
Additional services
Complementary human factors support
Support for every stage of your human factors program.
Accreditation
Accredited where it matters
Related services
Testing that usually goes with it
FAQ
Frequently asked questions
Is the report accepted by FDA as an ASCA report?
IEC 60601-1-6 is within our ASCA scope, so you receive an ASCA summary test report for your 510(k).
Is IEC 60601-1-6 the same as FDA human factors validation?
They are related but not the same. IEC 60601-1-6 checks your usability engineering process through IEC 62366-1; FDA also expects human factors validation results as described in its guidance. We help you line up both so one body of evidence supports the submission.
What do I need to send?
Your usability engineering file, the risk management file, the instructions for use and training materials, and access to the device or a representative prototype. We send a checklist with the quote.
How fast can I get a quote?
Within 24 hours. Tell us the device, its users and use environments, and we reply with scope, price and timeline.
Request a usability quote
Tell us about your device and the standards you need. You’ll have a quote within 24 hours.
(305) 239-4441 info@sigmascientific.us 490 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33325