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FDA ASCA accredited · TL-114

About Sigma Scientific

An independent medical device testing laboratory in Sunrise, Florida. We test medical electrical equipment and ultrasound systems for safety and performance, so manufacturers reach the market with evidence that holds up.

  • Sunrise, Florida
  • FDA ASCA TL-114
  • A2LA ISO/IEC 17025
Our services Accreditations
Have a device to test? Consult our specialists.

Who we are

Specialists who test medical devices

Sigma Scientific Services is a team of scientists, engineers and regulatory professionals specialized in biomedical, electrical and acoustic testing. We work with manufacturers from early design to the final test report for their FDA submission.

  • Independent testing laboratory for medical electrical equipment and ultrasound systems.
  • FDA ASCA accredited (TL-114) and accredited by A2LA to ISO/IEC 17025:2017.
  • Experience that adds up: each of our scientists, engineers and regulatory professionals brings years in a specialty, and together the team counts more than 80 years of medical device testing.
  • One team, one report: the same specialists plan, test and report, so nothing gets lost between steps.
Sigma Scientific medical device testing laboratory
A2LA ISO/IEC 17025:2017 accreditation certificate 4896.01 for Sigma Scientific Services LLC

Accreditation certificate

A2LA accredited to ISO/IEC 17025:2017

Sigma Scientific Services is an A2LA accredited laboratory under the ISO/IEC 17025:2017 standard. Certificate number 4896.01, valid to December 31, 2027. The PDF includes our full scope of accreditation.

View certificate and scope (PDF) All accreditations →

What we do

Testing that supports your submission

Accredited testing for your submission, and the engineering data your design team needs.

01UltrasoundAcoustic output, physiotherapy and high intensity therapeutic ultrasound.
02Medical electrical equipmentElectrical safety, alarm systems, usability and home use.
03Specialty devicesEndoscopes, infant incubators and transport incubators.
04Optics and materialsEndoscope optical performance accredited by A2LA, plus ultrasound gel and material testing.

See all services →

Our values

What we hold ourselves to

Knowledge and experienceExperience measured in people, not in company age: more than 80 years combined across the specialists who plan, run and review your tests.
QualityAccredited methods, calibrated equipment and reports reviewed clause by clause before they reach you.
TimingAccurate time estimates and early warnings, because your submission date matters.
Customer satisfactionWe aim to excel in timing, project cost, service and results, from the first quote to the final report.

In numbers

Accredited where it matters

11Standards in our FDA ASCA scope, from IEC 60601-1 to IEC 60601-2-62.See our ASCA scope →
10Accredited services: 9 within FDA ASCA, plus endoscope optics under A2LA.All services →
24 hQuote response with scope, price and timeline for your device.Request a quote →

Visit us

Our laboratory

Our laboratory is in Sunrise, Florida, in the Sawgrass corporate area of Broward County.

Sigma Scientific Services LLC

490 Sawgrass Corporate Parkway, Suite 130
Sunrise, FL 33325, USA

(305) 239-4441

info@sigmascientific.us

Get directions
  • Sample shipping and drop-off by appointment
  • Witness testing available on request
  • Secure handling of your devices and documents
  • Quote response within 24 hours

Consult with a medical device test expert

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