Scalability
From a single review to global submission support, we scale effortlessly to meet your project needs.
510(k) Submissions, Done Right
Get FDA-ready 510(k) packages delivered by regulatory experts trusted by leading medtech companies. Comprehensive predicate analysis, substantial equivalent documentation, and performance testing summaries that reviewers expect. Not sure you're ready to submit? Download our 510(k) Readiness Checklist.
What We Do: Comprehensive 510(k) Support and Medical Device Evidence Generation
Criterion Edge offers specialized services across the entire 510(k) submission lifecycle—from substantial equivalence documentation and predicate analysis to performance testing summaries, and strategic consulting for medical device clearance.
Pre-Submission Strategy & Readiness
- Regulatory pathway assessment and 510(k) strategy
- Predicate identification
- Substantial equivalence strategy
- Gap analysis of design controls, risk management, and testing readiness
- Support for FDA Q-Sub/Pre-Sub planning and briefing packages
510(k) Authoring & Submission
- Full 510(k) writing
- Device description, indications for use, and regulatory summaries
- Substantial equivalence comparisons and rationale
- Integration and summarization of bench, software, biocompatibility, sterilization, EMC/electrical safety, and usability testing
- Labeling review and alignment
- Standards declarations and administrative sections
Supporting Documentation Development
- Risk management documentation and regulatory justifications
- Software documentation (level of concern, architecture, V&V summaries)
- Test plans, protocols, and FDA-ready test summaries
- Clinical Data ( when required )
- Human factors and usability documentation support
Quality & Compliance Review
- Internal quality and consistency reviews across all submission sectionse
- STAR completeness and validation checks
- Alignment with current FDA guidance and review practices
- Final submission readiness review to minimize FDA follow-up
FDA Interaction & Post-Submission Support
- FDA submission coordination and eSTAR publishing support
- Drafting and management of FDA Additional Information (AI) responses
- Ongoing regulatory support through clearance
- Advisory support for post-clearance changes or future submissions
How We Work
Our Proven 5-Step 510(k) Workflow
We deliver efficient, FDA-ready 510(k) submissions through a transparent, collaborative process designed to reduce risk and keep programs moving.
1
Strategic Scoping & Alignment
We align early on device classification, regulatory pathway, predicate strategy, and submission goals to set a clear, defensible path forward.
Documentation & Evidence Review
We review your existing device documentation, testing data, and supporting evidence to confirm readiness and identify any gaps before drafting begins.
2
3
Equivalence & Evidence Integration
We integrate technical and clinical evidence and build clear, persuasive, substantial equivalence arguments aligned with FDA expectations.
Submission Development & Review
We develop a cohesive 510(k) within FDA’s eSTAR template, applying rigorous quality and compliance reviews to ensure clarity, consistency, and reviewability.
4
5
Submission & FDA Engagement
We finalize and support submission to the FDA and remain engaged through review, including management of FDA questions and Additional Information requests.
510(k) Premarket Notification Support
At Criterion Edge, we provide strategic, FDA-aligned 510(k) support that helps medical device manufacturers move efficiently from development to clearance. Our approach combines regulatory insight, technical rigor, and clear communication to support confident regulatory and market entry decisions.
Dedicated Regulatory Writers
Clients are supported by experienced regulatory writers who lead predicate identification, substantial equivalence strategy, and submission development—ensuring a focused, defensible approach tailored to each device.
Integrated Authoring Across Submission Sections
We develop and integrate technical, nonclinical, and clinical content within FDA’s eSTAR framework, ensuring consistency across device description, performance data, and substantial equivalence arguments, aligned with applicable FDA guidance and recognized standards.
Predictable, High-Quality Execution
Our team synthesizes device data, testing results, and supporting documentation into clear, submission-ready content, supported by structured quality and compliance reviews to minimize review risk and FDA follow-up.
Turning Device Data into Clearance
We translate complex technical information into persuasive regulatory narratives that support substantial equivalence, streamline FDA review, and help manufacturers advance their products to market with confidence.
Are You Ready for a 510(k) Submission?
From Traditional to Special and Abbreviated pathways, Criterion Edge delivers FDA-aligned 510(k) submissions that demonstrate substantial equivalence and support efficient device clearance.
Am I ready for a 510(k)?
- Download our 510(k) Readiness Checklist to assess your device data and predicate strategy
- Confirm required testing is complete, predicate devices identified, and a substantial equivalence approach is defined
- Identify gaps in performance data, labeling, biocompatibility, or other supporting documentation
When do I use a 510(k)?
- Traditional 510(k): For most new devices or significant changes requiring a full substantial equivalence review
- Special 510(k): For certain design modifications to a manufacturer’s own legally marketed device that do not change the intended use
- Abbreviated 510(k): When FDA guidance documents, special controls, or recognized consensus standards can be used to demonstrate substantial equivalence
What is a 510(k) used for?
- Obtain FDA clearance to market your medical device in the U.S
- Demonstrate substantial equivalence to a legally marketed predicate device
- Meet regulatory requirements for Class II and some Class I devices
A Team of experts at your service
Quality Assurance
Quality Assurance Manager
Medical Writers
PhD's, MD's, Scientists, Researchers
Literature Review Team
Medical Librarian, Clinical Evidence Experts
Project Oversight
Principal Writer / Strategic Leadership
Project Management
Project Management
A Purpose-Built Team for Every Project
Your 510(k) deserves more than just a freelancer. At Criterion Edge, each project is staffed with a dedicated, specialized team to ensure speed, consistency, and subject-matter accuracy.
Global Network of Experts
We tap into a distributed team with deep therapeutic and regulatory experience - working around the clock to move your project forward.
Specialized Roles, Unified Execution
You'll work with protocol developers, medical writers, and therapeutic-area experts aligned to your specific evidence needs.
Scalable, Flexible Staffing
Need to move faster or adjust scope? We scale resources up or down to meet your timeline and budget - without sacrificing quality.
Why Clients Choose Criterion Edge
We don't just check boxes - we partner with your team to deliver high-quality, submission-ready results. Here's what sets us apart:
Experience
Our team includes seasoned experts across regulatory, clinical, and therapeutic domains.
Quality
Built-in quality control ensures every deliverable is compliant, consistent, and audit-ready.
Efficiency
Streamlined workflows and dedicated project teams reduce turnaround time - without cutting corners.
What our clients have to say
Survey Responses
Below are the average scores (out of 5) for each of the criteria we ask our clients to grade us on after every project.
PAST AND UPCOMING WEBINARS
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HOT OFF THE PRESS
Why Leading MedTech & Pharma Teams Turn to Criterion Edge
Pharmaceutical and medical device companies face growing pressure to deliver high-quality, compliant evidence on tight timelines - with limited internal resources. Criterion Edge was built to fill that gap with expert-led, 510(k) services.
Meeting FDA 510(k) Standards With Confidence
Meeting FDA 510(k) Standards With Confidence From eSTAR compliance to substantial equivalence documentation and evolving FDA guidance, regulatory requirements demand expertise and vigilance. We navigate the pathway to clearance for you.
Demanding Reliability from Partners
Late reports, misaligned expectations, or unclear deliverables waste valuable time. Our team is known for quality, clarity, and on-time delivery.
Working Within Tight Budgets
Internal 510(k) teams can be costly and hard to scale. Outsourcing with us helps you meet your evidence goals while staying within budget.
Bridging the Talent Gap
510(k) expertise is niche and hard to hire. Our experienced writers and reviewers are ready to support your projects right now.
Meet Our Founder: Laurie Mitchell, CEO
With over two decades in the pharmaceutical and medical device sectors, Laurie Mitchell saw firsthand how regulatory and clinical teams struggled with the complexities of 510(k) submissions. She launched Criterion Edge to deliver high-quality regulatory evidence and documentation that bridges the gap between technical requirements and submission-ready reports.
Under her leadership, Criterion Edge has supported top global brands across 510(k) submissions, predicate device analysis, and regulatory strategy—providing expert-written, fully documented deliverables trusted by teams around the world.
Ready to Streamline Your Evidence Process?
Let’s discuss your 510(k) needs and how Criterion Edge can support your strategic objectives.