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 for their end-to-end solutions rooted in scientific rigor and regulatory clarity.
**Expertise & scope**
* Ultrasound Probe Repair: Offering depot-level repairs for various makes and models, including TEE and general/endocavity probes, validated against OEM specifications.
* Ultrasound Probe Testing: Providing ISO/IEC 17025:2017 accredited testing to verify repair integrity and restore acoustic performance to OEM specifications.
* Acoustic Measurement & Calibration Services: Performing certified ultrasound measurements and calibrations in an ISO/IEC 17025:2017 and FDA ASCA accredited laboratory.
* FDA 510(k) Submission & Consulting Services: Assisting with the development and preparation of 510(k) submission content for diagnostic ultrasound devices.
* Contract Engineering & R&D: Focusing on the development of ultrasound medical imaging systems, probes, and related devices, including low-volume manufacturing.
**Reputation / proof points**
* Over 27 years of experience in ultrasound probe repair, having repaired more than 184,000 probes.
* Operates as the world's largest probe repair facility.
* ISO13485:2016 certified repair process.
* ISO/IEC 17025:2017 accredited laboratory for testing and acoustic measurements.
* FDA ASCA accredited laboratory.
* Directly involved in the successful filing of over 700 510(k) submissions.
Acertara Acoustic Laboratories LLC is a specialized provider of ultrasound probe services, focusing on testing, repair, calibration, and regulatory support. They are recognized for their end-to-end solutions rooted in scientific rigor and regulatory clarity.
**Expertise & scope**
* Ultrasound Probe Repair: Offering depot-level repairs for various makes and models, including TEE and general/endocavity probes, validated against OEM specifications.
* Ultrasound Probe Testing: Providing ISO/IEC 17025:2017 accredited testing to verify repair integrity and restore acoustic performance to OEM specifications.
* Acoustic Measurement & Calibration Services: Performing certified ultrasound measurements and calibrations in an ISO/IEC 17025:2017 and FDA ASCA accredited laboratory.
* FDA 510(k) Submission & Consulting Services: Assisting with the development and preparation of 510(k) submission content for diagnostic ultrasound devices.
* Contract Engineering & R&D: Focusing on the development of ultrasound medical imaging systems, probes, and related devices, including low-volume manufacturing.
**Reputation / proof points**
* Over 27 years of experience in ultrasound probe repair, having repaired more than 184,000 probes.
* Operates as the world's largest probe repair facility.
* ISO13485:2016 certified repair process.
* ISO/IEC 17025:2017 accredited laboratory for testing and acoustic measurements.
* FDA ASCA accredited laboratory.
* Directly involved in the successful filing of over 700 510(k) submissions.
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 process emphasizes the use of validated materials and components, ensuring that repairs meet or exceed OEM specifications. For final testing, they employ Advantage™ 2.0 tissue mimicking phantoms to confirm acoustic performance. Buyers should note that Acertara's services are designed to mitigate future probe failures and expenses by addressing potential issues during the repair process.
Key Highlights
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Over 27 years of experience in ultrasound probe repair, with more than 184,000 probes repaired.
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 as the world's largest probe repair facility.
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 measurements.
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 power measurement, calibration, and testing.
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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Involved in over 700 successful 510(k) submissions for 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.”
Certifications & Trust Signals
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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.”
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Accredited to ISO/IEC 17025:2017 for contract engineering services.
Source
“Acertara operates in an ISO13485:2016 certified environment and is accredited to ISO/IEC17025:2017.”
Buyer Snapshot
Best for
- Medical device manufacturers requiring probe repair and validation.
- Companies seeking FDA 510(k) submission support for ultrasound devices.
- Research institutions needing specialized acoustic measurement and calibration services.
How engagement typically works
- Project-based consulting and services.
- Collaborative development for contract engineering.
Typical deliverables
- Validated ultrasound probe repairs.
- Accredited ultrasound probe testing reports.
- Certified acoustic measurement and calibration data.
- FDA 510(k) submission documentation.
- Developed ultrasound system and probe prototypes.
Good to know
- Best when requiring specialized expertise in ultrasound probe technology and regulatory compliance.
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
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
Acoustic Measurement, Calibration, Electrical Leakage Testing, Probe Repair Validation
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
Custom
