Acertara Acoustic Laboratories LLC
Acertara Acoustic Laboratories offers specialized services for diagnostic ultrasound probes, including repair, testing, calibration, and FDA 510(k) submission consulting. They ensure probe safety and performance for healthcare providers.
Acertara Acoustic Laboratories LLC is a leading provider of specialized services for diagnostic ultrasound probes, dedicated to enhancing probe performance, safety, and extending their lifecycle. They offer comprehensive solutions including expert probe repair, validated ultrasound probe testing under ISO/IEC 17025:2017 standards, and precise acoustic measurement & calibration services. With extensive experience and ISO13485:2016 certification, Acertara assists clients in navigating the complexities of FDA 510(k) submissions and regulatory consulting, streamlining the device clearance process. Their world-class R&D team utilizes patented testing devices and adheres to rigorous scientific and regulatory standards to ensure the highest quality outcomes for healthcare providers, research laboratories, and medical device manufacturers. Acertara's commitment to innovation, integrity, and accuracy makes them a trusted partner for maintaining the reliability and safety of critical medical equipment, ultimately contributing to better patient care and sustainable cost management within the healthcare industry.
About
**Who they are**
Acertara Acoustic Laboratories LLC is a specialized provider of ultrasound probe services, focusing on testing, repair, calibration, and regulatory support. They are recognized as the world's largest probe repair facility.
**Expertise & scope**
* End-to-end solutions for ultrasound probe services including testing, repair, calibration, and regulatory support.
* FDA 510(k) submission consulting and contract engineering.
* Specialized services for diagnostic ultrasound probes, ensuring safety and performance.
* Development, filing, and post-market surveillance for ultrasound devices.
* Acoustic validation compliant with IEC standards.
* Repair services validated against OEM specifications.
* Electrical leakage testing and tissue mimicking phantom testing.
* Contract engineering for ultrasound medical imaging systems, probes, and related devices.
**Reputation / proof points**
* Over 27 years of experience in ultrasound probe repair, with more than 184,000 probes repaired.
* ISO13485:2016 certified repair process.
* ISO/IEC 17025:2017 accredited laboratory for ultrasound probe testing and acoustic measurement services.
* FDA ASCA accredited laboratory.
* Direct involvement in over seven hundred 510(k) submissions for ultrasound devices.
Acertara Acoustic Laboratories LLC is a specialized provider of ultrasound probe services, focusing on testing, repair, calibration, and regulatory support. They are recognized as the world's largest probe repair facility.
**Expertise & scope**
* End-to-end solutions for ultrasound probe services including testing, repair, calibration, and regulatory support.
* FDA 510(k) submission consulting and contract engineering.
* Specialized services for diagnostic ultrasound probes, ensuring safety and performance.
* Development, filing, and post-market surveillance for ultrasound devices.
* Acoustic validation compliant with IEC standards.
* Repair services validated against OEM specifications.
* Electrical leakage testing and tissue mimicking phantom testing.
* Contract engineering for ultrasound medical imaging systems, probes, and related devices.
**Reputation / proof points**
* Over 27 years of experience in ultrasound probe repair, with more than 184,000 probes repaired.
* ISO13485:2016 certified repair process.
* ISO/IEC 17025:2017 accredited laboratory for ultrasound probe testing and acoustic measurement services.
* FDA ASCA accredited laboratory.
* Direct involvement in over seven hundred 510(k) submissions for ultrasound devices.
Additional information
Acertara Acoustic Laboratories leverages its ISO/IEC 17025:2017 and FDA ASCA accredited laboratory to provide certified ultrasound measurement services. Their expertise extends to supporting national and international standards, including IEC60601-2-37, IEC60601-2-5, ISO14708-1, and ISO60601-2-62. The company emphasizes a rigorous approach to testing and calibration, ensuring accuracy and timeliness for clients ranging from established medical device OEMs to university research laboratories and startup companies. Their professional staff brings extensive combined experience in ultrasound system design, measurement, and regulatory affairs.
Key Highlights
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World's largest probe repair facility with over 184,000 probes repaired since 1998.
Source
“Now as the world’s largest probe repair facility, we also perform depot-level repairs for several industry leading ultrasound OEMs.”
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ISO/IEC 17025:2017 accredited laboratory for ultrasound probe testing and acoustic measurement services.
Source
“Acertara Acoustic Laboratories provides a complete suite of certified ultrasound measurement services through our ISO/IEC 17025:2017 and FDA ASCA accredited laboratory”
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Over twenty years of experience directly involved in the successful filing of more than seven hundred 510(k) submissions.
Source
“Over the last twenty plus years Acertara has been directly involved in the successful filing of more than seven hundred 510(k) submissions for ultrasound systems, probes, active implantables, and other ultrasound related devices.”
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Operates in an ISO13485:2016 certified environment for repair processes.
Source
“Acertara operates in an ISO13485:2016 certified environment and is accredited to ISO/IEC17025:2017.”
Certifications & Trust Signals
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ISO/IEC 17025:2017 accredited for ultrasound probe testing.
Source
“ISO/IEC 17025:2017 accredited ultrasound probe testing is the benchmark for repair integrity.”
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FDA ASCA accredited laboratory for acoustic measurement and calibration services.
Source
“Acertara Acoustic Laboratories provides a complete suite of certified ultrasound measurement services through our ISO/IEC 17025:2017 and FDA ASCA accredited laboratory”
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ISO13485:2016 certified environment for repair processes.
Source
“Next we use validated materials and components in our ISO13485:2016 repair process.”
Buyer Snapshot
Best for
- Medical device manufacturers requiring ultrasound probe testing and validation.
- Companies seeking FDA 510(k) submission support for diagnostic ultrasound devices.
- Healthcare providers needing specialized ultrasound probe repair and calibration.
How engagement typically works
- Project-based consulting and engineering services.
- Depot-level repair services for ultrasound probes.
- Collaborative development for new ultrasound technologies.
Typical deliverables
- Validated ultrasound probe testing reports.
- Completed FDA 510(k) submission packages.
- Repaired and calibrated ultrasound probes.
- Contract engineering designs and prototypes.
Good to know
- Best when requiring services aligned with ISO/IEC 17025 and FDA ASCA accreditation.
- Ideal for complex ultrasound probe repairs and acoustic measurements.
HQ:
Longmont, US
Languages:
English
Timezones:
UTC-7, UTC-6
Claim status:
Listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Countries:
United States, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Standards Supported:
IEC 60601-1, IEC 60601-1-2
Is Accredited:
Yes
Accreditation Body:
NVLAP
Accreditation Scope Document Url:
https://acertaralabs.com/services/acoustic-measurement-calibration-service/
Test Coverage:
EMC only
Nrtl Relationships:
UL, TUV, Intertek, CSA
Cb Scheme Support:
Yes
Chamber Type:
Semi-anechoic
Frequency Range:
10 kHz to 40 GHz
Pre Scan Debug Support:
Yes
On Site Testing Option:
Yes
Wireless Add On Capability:
Yes
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Rush Available:
Yes
Test Types Offered:
Conducted emissions, Radiated emissions, ESD immunity, EFT immunity, Surge immunity, RF immunity, Dips/interruptions, Voltage variations
Regions Served:
North America, Europe, Asia, Global
Sample Return Policy:
Return
Nda Support:
Yes
Minimum Project Size:
<$10k
Max Eut Size:
Custom
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601-2-37, IEC 60601-2-5, ISO14708-1, ISO60601-2-62, ISO/IEC 17025:2017, ISO13485:2016
Test Coverage
Safety, EMC, Electrical Safety, Acoustic Measurement, Calibration, Acoustic Testing, Acoustic Performance
Nrtl Relationships
FDA ASCA
Max Eut Size
Ultrasound Probes and Systems
Chamber Type
N/A
Lead Time Band
N/A
Quote SLA
N/A
Test Types Offered
Ultrasound Probe Testing, Acoustic Measurement & Calibration, Electrical Leakage Testing
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
Custom
