Team Elexes 
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510(k) Submission Consultants for FDA Clearance
At Elexes, we specialize as 510(k) submission consultants for medical device companies aiming to bring their innovations to the U.S. market. With a proven track record of successful FDA clearances, our team ensures your submission is accurate, complete, and strategically crafted to reduce review times and regulatory pushback.
Whether you're a startup or an established OEM, our FDA regulatory experts will guide you through predicate device selection, documentation, and direct communication with the FDA.
What Is a 510(k) Submission and Why You Need Expert Support for 510(k) Submission
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A 510(k) submission is a premarket notification required by the FDA for most Class II medical devices submission to demonstrate substantial equivalence to a legally marketed device (predicate). To get it right the first time can be challenging and time-consuming.
Why consultants matter:
⦿ Reduce the risk of Refuse to Accept (RTA) or Additional Information (AI) requests
⦿ Identify the most suitable predicate device
⦿ Prepare compliant documentation aligned with FDA requirements
⦿ Ensure faster time-to-market and avoid costly delays
Our consultants don’t just file documents; they strategize, optimize, and advocate for your product.
Why Choose Elexes as Your 510(k) Partner?
We go beyond just ticking regulatory boxes. Elexes helps you build a 510(k) that tells the right story to the FDA, from intended use and indications for use to testing strategy and labeling.
Our 510(k) consulting services include:
⦿ Device classification and regulatory pathway assessment
⦿ Predicate device search & justification
⦿ Technical documentation & test protocols
⦿ Labeling compliance and IFU review
⦿ FDA eSTAR template preparation and submission
Whether your device is mechanical, electromechanical, software-based, or a SaMD, Elexes delivers clarity and confidence every step of the way.
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Our Comprehensive 510(k) Consulting Services
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Our team customizes 510(k) submissions based on your product type and business goals.
Define optimal regulatory pathway, testing requirements, and submission format (traditional, special, or abbreviated 510(k)).
Find and justify the most suitable predicate with a detailed, substantial equivalence discussion.
Compile and QC all sections of the FDA 510(k), including technical descriptions, performance data, and labeling.
Ensure bench, biocompatibility, software, and electrical safety tests align with FDA-recognized standards.
We help with eSTAR formatting, eCopy creation, and respond to FDA queries promptly to avoid delays.
In-Depth Expertise Across Device Types
Our consultants bring deep regulatory experience across all major device categories, ensuring tailored support for your unique product.
Class II Medical Devices
From orthopedic instruments to diagnostic imaging, we manage the full 510(k) lifecycle to meet FDA expectations.
Software as a Medical Device (SaMD)
Our experts ensure compliance with IEC 62304, FDA guidance on software, cybersecurity, and usability standards.
Combination Products
Navigating devices with drug or biologic components? We help align your submission with FDA’s Office of Combination Products (OCP) requirements.
Sterile and Reusable Devices
We manage sterilization validations (ISO 11135, 11737), reprocessing instructions, and packaging integrity testing.
In Vitro Diagnostic Devices
Leverage our IVD regulatory experience with data-intensive submissions and CLIA categorization requirements.
AI/ML-Enabled Devices
We guide companies through Good Machine Learning Practice (GMLP) principles and real-world performance testing.
Your FDA 510(k) Roadmap Simplified
With Elexes, regulatory compliance doesn’t have to be overwhelming. We break it down into actionable steps.
Ready to Clear Your Device With Confidence?
Avoid setbacks. Submit with precision.
Partner with Elexes. Your trusted 510(k) submission experts.
Ready to get your custom checklist with timelines and templates?
FAQs
Frequently Asked Questions!
A 510(k) is a FDA premarket notification submitted to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device.
Most manufacturers of Class II medical devices need to file a 510(k) before marketing their product in the U.S.
Typically, the FDA takes 90 days to review a Traditional 510(k). Special and Abbreviated 510(k)s have shorter timelines.
Why Should You Hire Elexes as an LDT Regulatory Consultant?
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Our medical devices’ internal audit team can help you with -
- Supplier audits
- Current Good Manufacturing Practices (cGMP) compliance audit
- Current Good Laboratory Practices (cGLP) compliance audit
- Regulatory Gap analysis
- CFR Part 11 Gap analysis
- Pre-approval audits
- Risk assessment
- Development of inspection checklists
- Quality system audits (21 CFR 820 audit / ISO 13485 Audit)
- MDSAP audit
Looking for professional audit support?
Look no further!
Our Services
If you are looking for LDT/IVD/IVDR Consulting services, Elexes is one of the trusted RA/QA consultants. We have helped several LDT and IVD companies not only get medical device clearance from the associated regulatory body but also help them stay compliant with our post-market compliance consulting services.
Compliance Assurance
Stay compliant with industry regulations and standards.
Cost-effective
Achieve regulatory success with Elexes, all within your budget.
Why choose
Elexes for medical device regulatory & compliance services?
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
We’ve More
Than 256+ Global
Clients
The Best RA & QA Consultants
Clients Testimonials
Amazing Feedback About Our Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
“
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