Acertara Labs
Expert FDA 510(k) Regulatory Consultant specializing in Ultrasound and Implant Devices | 20 Years Experience
Acertara Labs is a distinguished full-service CRO with 20 years of specialized experience in FDA 510(k) regulatory consulting. They possess profound expertise in ultrasound devices, having successfully managed hundreds of 510(k) submissions in this area, and also offer significant capabilities in implant devices. Acertara Labs guides medical device companies through FDA regulatory pathways, ensuring successful 510(k) clearances for Class II and Class III devices, particularly within the radiology specialty, serving clients globally.
About
**Who they are**
Acertara Labs is a regulatory consultant specializing in FDA 510(k) submission services, with over 20 years of experience. They focus on ultrasound and implant devices.
**Expertise & scope**
* FDA 510(k) submission consulting and preparation for diagnostic ultrasound devices, probes, active implantables, and related products.
* Development and filing support, including strategy and full turn-key submissions.
* Assistance with post-market surveillance.
* Expertise in acoustic power measurement, calibration, and testing, with an ISO/IEC 17025:2017 and FDA ASCA accredited laboratory.
* Contract engineering services for ultrasound medical imaging systems and devices.
* Low-volume manufacturing of ultrasound probes and systems.
**Reputation / proof points**
* Over 20 years of experience.
* Directly involved in the successful filing of more than 700 510(k) submissions.
* ISO/IEC 17025:2017 accredited laboratory.
* FDA ASCA accredited laboratory.
* ISO13485:2016 certified environment.
Acertara Labs is a regulatory consultant specializing in FDA 510(k) submission services, with over 20 years of experience. They focus on ultrasound and implant devices.
**Expertise & scope**
* FDA 510(k) submission consulting and preparation for diagnostic ultrasound devices, probes, active implantables, and related products.
* Development and filing support, including strategy and full turn-key submissions.
* Assistance with post-market surveillance.
* Expertise in acoustic power measurement, calibration, and testing, with an ISO/IEC 17025:2017 and FDA ASCA accredited laboratory.
* Contract engineering services for ultrasound medical imaging systems and devices.
* Low-volume manufacturing of ultrasound probes and systems.
**Reputation / proof points**
* Over 20 years of experience.
* Directly involved in the successful filing of more than 700 510(k) submissions.
* ISO/IEC 17025:2017 accredited laboratory.
* FDA ASCA accredited laboratory.
* ISO13485:2016 certified environment.
Additional information
Acertara Labs offers a comprehensive approach to FDA 510(k) submissions, integrating their expertise in acoustic testing and calibration with regulatory strategy. Their services are designed to streamline and expedite the clearance process for diagnostic ultrasound devices and related technologies. They emphasize scientific rigor and regulatory clarity in all their offerings, from initial submission consulting to post-market surveillance. Buyers can expect a partner with deep technical understanding of ultrasound devices, backed by extensive experience in regulatory affairs and device development.
Key Highlights
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Over 20 years of experience in FDA 510(k) submission consulting.
Source
“Over the last twenty plus years Acertara has been directly involved in the successful filing of more than seven hundred 510(k) submissions”
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Successfully filed over 700 510(k) submissions for ultrasound systems, probes, and active implantables.
Source
“Over the last twenty plus years Acertara has been directly involved in the successful filing of more than seven hundred 510(k) submissions”
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Operates an ISO/IEC 17025:2017 accredited acoustic measurement and testing 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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FDA ASCA accredited laboratory for acoustic power measurement and calibration.
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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Operates in an ISO13485:2016 certified environment.
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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ISO13485:2016 certified for repair processes.
Source
“Next we use validated materials and components in our ISO13485:2016 repair process.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) clearance for ultrasound devices.
- Companies needing specialized acoustic testing and calibration services.
- Firms requiring contract engineering and R&D support for ultrasound technology.
How engagement typically works
- Consultative approach to submission strategy.
- Partnership for full turn-key submission preparation.
- Project-based support for engineering and testing.
Typical deliverables
- FDA 510(k) submission documentation.
- Acoustic measurement and calibration reports.
- Validated ultrasound probe testing results.
- Prototype designs and low-volume manufactured devices.
Good to know
- Best when focused on ultrasound and implantable devices.
- Engagement is most effective when leveraging their specialized laboratory services.
HQ:
United States
Languages:
English
Timezones:
America/Denver
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, SaMD, Combination product
Supports Predicate Research:
Yes
Years Experience:
15
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
In Vitro Diagnostic (IVD), Medical Device
Technology Types:
Software as a Medical Device (SaMD), Combination Product
Engagement Models:
Project-based, Retainer
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Num510k Submitted:
100
Product Code Experience:
Class II, Class III
Typical Lead Time Weeks:
12
Response Time Hours:
24
