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 submission consulting and IEC-compliant acoustic validation.
* Specialized services in probe repair, acoustic measurement, calibration, and contract engineering.
* Development, filing, and post-market surveillance for ultrasound devices.
* Expertise in diagnostic ultrasound devices, probes, active implantables, and related equipment.
**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.
* Involved in the successful filing of over 700 510(k) submissions for ultrasound devices.
* Operates an ISO13485:2016 certified environment and is accredited to ISO/IEC17025:2017 for contract engineering.
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 submission consulting and IEC-compliant acoustic validation.
* Specialized services in probe repair, acoustic measurement, calibration, and contract engineering.
* Development, filing, and post-market surveillance for ultrasound devices.
* Expertise in diagnostic ultrasound devices, probes, active implantables, and related equipment.
**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.
* Involved in the successful filing of over 700 510(k) submissions for ultrasound devices.
* Operates an ISO13485:2016 certified environment and is accredited to ISO/IEC17025:2017 for contract engineering.
Additional information
Acertara Acoustic Laboratories utilizes proprietary testing devices such as the ATLAS™ Ultrasound Probe Tester and AmpSafe™ 2.0 electrical leakage tester for comprehensive diagnostics and validation. Their repair processes are validated against OEM specifications, and they employ validated materials and components. For final testing, they use the Advantage™ 2.0 tissue mimicking phantom. The company emphasizes thorough inspection to identify and address potential issues during repair, aiming to mitigate future failures and expenses for their clients. They offer services supporting various national and international standards, including IEC60601-2-37, IEC60601-2-5, ISO14708-1, and ISO60601-2-62.
Key Highlights
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Over 27 years of experience in ultrasound probe repair, having serviced more than 184,000 probes.
Source
“Since introducing contemporary ultrasound probe repair to the hospital market over 27 years ago, we’ve repaired more than 184,000 probes of all makes, models, and complexity.”
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Operates an 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 in Longmont, Colorado.”
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Directly involved in the successful filing of over 700 510(k) submissions for various ultrasound devices.
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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Utilizes proprietary testing devices like ATLAS™ for probe failure diagnosis down to the element or component level.
Source
“With our patented ATLAS™ testing device, we quickly diagnose probe failures down to the element or component level.”
Certifications & Trust Signals
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ISO13485:2016 certified repair process.
Source
“Next we use validated materials and components in our ISO13485:2016 repair process.”
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Accredited to ISO/IEC 17025:2017 for ultrasound probe testing and contract engineering services.
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 in Longmont, Colorado.”
Buyer Snapshot
Best for
- Medical device manufacturers requiring specialized ultrasound probe testing and repair.
- Companies seeking FDA 510(k) submission consulting for diagnostic ultrasound devices.
- Organizations needing contract engineering and R&D for ultrasound systems and probes.
How engagement typically works
- Project-based consulting and services.
- Collaborative approach for regulatory submissions.
- End-to-end service delivery from testing to repair.
Typical deliverables
- Validated ultrasound probe repair reports.
- Acoustic measurement and calibration reports.
- FDA 510(k) submission documentation.
- Contract engineered ultrasound device prototypes.
Good to know
- Best when requiring ISO/IEC 17025:2017 accredited testing and FDA ASCA accreditation.
HQ:
Longmont, US
Languages:
English
Timezones:
UTC-7, UTC-6
Status:
listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Countries:
United States, Europe
Industries:
Medical Devices
Standards Supported:
ISO/IEC 17025
Is Accredited:
Yes
Accreditation Body:
FDA
Accreditation Scope Document Url:
https://acertaralabs.com/services/acoustic-measurement-calibration-service/
Test Coverage:
Safety only
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
Nrtl Relationships
FDA ASCA
Max Eut Size
Custom
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
