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: Offers depot-level repairs for various makes and models, validated against OEM specifications, with over 184,000 probes repaired since 1998.
* Ultrasound Probe Testing: Provides ISO/IEC 17025:2017 accredited testing to verify acoustic performance and repair integrity, utilizing diagnostic-grade protocols.
* Acoustic Measurement & Calibration: Conducts certified ultrasound measurement services under ISO/IEC 17025:2017 and FDA ASCA accreditation.
* FDA 510(k) Submission & Consulting: Assists in developing and preparing 510(k) submission content for diagnostic ultrasound devices, with a history of over 700 successful filings.
* Contract Engineering & R&D: Focuses on the development of ultrasound medical imaging systems, probes, and related devices, including novel technologies and low-volume manufacturing.
**Reputation / proof points**
* ISO13485:2016 certified repair process.
* ISO/IEC 17025:2017 accredited laboratory for ultrasound probe testing and acoustic measurements.
* FDA ASCA accredited laboratory.
* Over 27 years of experience in ultrasound probe repair.
* Utilizes proprietary testing devices like ATLAS™ Ultrasound Probe Tester and AmpSafe™ 2.0 electrical leakage tester.
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: Offers depot-level repairs for various makes and models, validated against OEM specifications, with over 184,000 probes repaired since 1998.
* Ultrasound Probe Testing: Provides ISO/IEC 17025:2017 accredited testing to verify acoustic performance and repair integrity, utilizing diagnostic-grade protocols.
* Acoustic Measurement & Calibration: Conducts certified ultrasound measurement services under ISO/IEC 17025:2017 and FDA ASCA accreditation.
* FDA 510(k) Submission & Consulting: Assists in developing and preparing 510(k) submission content for diagnostic ultrasound devices, with a history of over 700 successful filings.
* Contract Engineering & R&D: Focuses on the development of ultrasound medical imaging systems, probes, and related devices, including novel technologies and low-volume manufacturing.
**Reputation / proof points**
* ISO13485:2016 certified repair process.
* ISO/IEC 17025:2017 accredited laboratory for ultrasound probe testing and acoustic measurements.
* FDA ASCA accredited laboratory.
* Over 27 years of experience in ultrasound probe repair.
* Utilizes proprietary testing devices like ATLAS™ Ultrasound Probe Tester and AmpSafe™ 2.0 electrical leakage tester.
Additional information
Acertara Acoustic Laboratories LLC emphasizes the importance of validated testing for probe repair integrity, stating that repairs without ultrasound probe testing for validation are not reliable. They employ diagnostic-grade protocols and calibrated measurement systems, ensuring that acoustic testing is accurate, repeatable, and traceable. Their services are designed to meet the highest standards, supporting healthcare providers in ensuring probe safety and performance. For regulatory submissions, they offer consulting strategies and full turn-key solutions to streamline the clearance process for diagnostic ultrasound devices.
Key Highlights
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Offers ISO/IEC 17025:2017 accredited ultrasound probe testing.
Source
“ISO/IEC 17025:2017 accredited ultrasound probe testing is the benchmark for repair integrity.”
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Provides FDA ASCA accredited 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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Has successfully filed over 700 510(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.”
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Operates with an ISO13485:2016 certified repair process.
Source
“Next we use validated materials and components in our ISO13485:2016 repair process.”
Certifications & Trust Signals
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Accredited to ISO/IEC 17025:2017 for ultrasound probe testing and acoustic measurements.
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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FDA ASCA accredited laboratory.
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 27 years of experience in ultrasound probe repair, having repaired 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.”
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.
How engagement typically works
- Project-based consulting and engineering.
- Service contracts for repair and testing.
- Collaborative R&D partnerships.
Typical deliverables
- Validated ultrasound probe repairs.
- Accredited acoustic testing reports.
- FDA 510(k) submission documentation.
- Custom ultrasound device prototypes.
Good to know
- Best when requiring services compliant with ISO/IEC 17025 and FDA ASCA standards.
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, Tissue Mimicking Phantom Testing
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
Custom
