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Frequently asked questions

Samples, timelines, reports and accreditation scope, answered. If your question is not here, consult a specialist.

  • Quotes
  • Samples
  • Timelines
  • Reports
  • Accreditation

01Quotes & scope

How do I request a quote?

Send the form below or call (305) 239-4441 with your device, model and the standards you need. You will have a quote within 24 hours.

What information do you need to quote?

The device type and model, its intended use, the standards and editions you need, the number of models or configurations, and your target submission date. A user manual or data sheet helps us scope the test plan.

Not sure which standards apply to your device?

Tell us about the device and its market. A specialist will help you scope the standards and the test plan before you ship samples.

Can you run a single measurement instead of a full standard?

Yes. Many clients need one measurement, such as acoustic power, leakage current or temperature rise. See our measurements.

Do you work with manufacturers outside the US?

Yes. We work with manufacturers in the USA, Europe, Asia and Latin America.

02Samples

How many samples do you need?

It depends on the standard. For acoustic output testing, we typically need a minimum of three transducers per imaging mode for statistical significance. For electrical safety, one representative unit per configuration is usually enough.

What should I ship with the device?

Accessories, cables and probes used in normal operation, the instructions for use, and any software or service mode needed to reach the test conditions.

Where do I send samples?

Sigma Scientific Services, 490 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33325. Contact us before shipping so we can register the samples to your project.

Do you return the samples?

Yes, after testing, at your cost and with the carrier you choose.

03Timelines

How long does testing take?

It depends on the standards and the number of configurations. We confirm the schedule in the quote, with a start date and a report date.

Can you expedite testing?

Tell us your submission date when you request the quote and we will tell you what we can do.

What delays a project most often?

Missing accessories or software, a device that is not in its final configuration, and test plans without agreed acceptance criteria. Our ASCA checklist covers these points.

04Reports

What does the test report include?

The test methods, the measurement setup, calibrated instrumentation, environmental conditions, results against the requirements, uncertainty where it applies, and photos or plots of the setup and data.

Do I get an ASCA summary test report?

Yes, for standards within our ASCA scope you receive the ASCA summary test report together with the complete test report.

In what format and language are reports issued?

In English, as signed PDF documents.

What happens if my device fails a test?

We report the result and the clause involved, and we discuss with you what was observed so your team can decide on changes and a retest.

05Accreditation

Which accreditations does Sigma hold?

Sigma Scientific Services is an FDA ASCA accredited testing laboratory (TL-114) and is accredited by A2LA to ISO/IEC 17025:2017, certificate 4896.01. See our accreditations.

Which standards are in your ASCA scope?

Eleven standards: IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-6, -1-8, -1-11, -2-5, -2-18, -2-19, -2-20, -2-37 and -2-62.

Can I get a copy of your certificates?

Yes. Our A2LA certificate and scope are on our accreditations page, and we can send them with your quote.

What is ASCA and how does it help my 510(k)?

Read our ASCA program guide.

06Working with us

Will you sign an NDA?

Yes. We can work under your NDA or ours before you share design information.

Can I witness the testing?

Yes, by appointment at our laboratory in Sunrise, Florida.

Can you help during development, before formal testing?

Yes. Pre-compliance testing during development helps you find problems early, when changes are cheaper.

Still have a question?

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

Request a Quote