Hiring a 510(k) Consultant vs. Using AI Software
When facing the complexities of an FDA 510(k) submission, the first instinct for many MedTech companies is to hire a regulatory consultant. But what do they really cost, and is there a better way? This guide breaks down the traditional consulting model and compares it to the new paradigm of AI-powered submission software.
What Does a 510(k) Consultant Do? (And What Do They Cost?)
A good regulatory consultant is an expert guide. They provide strategic advice, help you navigate the regulatory landscape, and handle the heavy lifting of drafting and managing your submission.
Typical Services Include:
- Regulatory strategy and device classification.
- Predicate device analysis.
- Drafting the entire 510(k) submission.
- Communicating with the FDA on your behalf.
The Cost: This expertise comes at a significant price. A full-service 510(k) submission project with a consultant can range from **$20,000 to over $100,000**, depending on the complexity of your device and the scope of their involvement.
A Head-to-Head Comparison: Consultant vs. Cruxi AI
AI-powered software like Cruxi isn't designed to replace strategic advice, but to automate the most time-consuming and error-prone parts of the 510(k) process: drafting and document management.
| Factor | Traditional 510(k) Consultant | Cruxi AI Platform |
|---|---|---|
| Cost | $20,000 - $100,000+ | A fraction of the cost |
| Speed | Months of manual drafting and review cycles. | Generates first drafts in days; cuts total time by up to 70%. |
| Knowledge Transfer | The knowledge often leaves when the contract ends. | Your data and submission logic remain in your secure workspace, creating a permanent asset. |
| Control & Visibility | Can be a "black box" process with limited visibility. | Full control and transparency for your in-house team at every step. |
| Consistency | Reliant on human attention to detail. | AI ensures perfect consistency across all sections, from the IFU to the SE narrative. |
Empower Your Team, Don't Outsource Your Knowledge.
Cruxi gives your in-house team the power of a top-tier consultant by automating the manual work. You get to market faster, save thousands, and build a reusable regulatory knowledge base.
See How Cruxi WorksThe Hybrid Approach: The Best of Both Worlds
The smartest regulatory strategy often isn't an "either/or" choice. The hybrid model allows you to maximize value and efficiency:
- Use Cruxi for the Heavy Lifting: Empower your in-house team to manage the data, generate 80% of the draft submission using AI, and ensure eSTAR compliance from day one.
- Use a Consultant for High-Level Strategy: Engage a consultant for a much smaller, fixed-fee contract to review the final AI-generated submission, provide strategic advice on borderline predicate cases, and assist with FDA communication.
This approach saves you tens of thousands of dollars in consulting fees, dramatically accelerates your timeline, and ensures you still have expert oversight for the most critical strategic decisions.
How Cruxi Radically Enhances Quality
Discover the 10 superhuman capabilities that set Cruxi apart from traditional consulting and manual processes
What Cruxi Does
Scans ~2,300+ regulations and thousands of guidance/special controls in seconds to see what might apply to your device.
Why No Human Can Match This
A human has to search, open, read, and interpret each source manually. Doing this exhaustively is practically impossible under time and budget pressure.
Quality & Business Impact
You don't "miss a regulation" because someone forgot a keyword. Stronger compliance baseline, fewer blind spots.
What Cruxi Does
Matches your device against thousands of product codes and 10,000s of cleared devices with complex algorithms (indications, tech, risk) to shortlist the best predicates.
Why No Human Can Match This
Humans scan a handful of devices and rely on experience and Google/510(k) search. Nobody can manually compare against tens of thousands consistently.
Quality & Business Impact
Much better predicate selection: tighter similarity, less FDA pushback, fewer AI/RTA questions, lower NSE risk.
What Cruxi Does
Evaluates MAUDE events, recalls, safety communications and recent clearances together when ranking predicates and shaping your strategy.
Why No Human Can Match This
Humans rarely have time to deeply cross-check adverse events and recalls for every candidate predicate, let alone in real time.
Quality & Business Impact
Avoid "toxic" predicates with bad post-market history. Better risk story, safer device positioning, and fewer surprises later.
What Cruxi Does
Generates a device-specific testing matrix in seconds (bench, software, EMC, biocomp, electrical safety, usability, cybersecurity, etc.) mapped to regulations, guidance, and standards.
Why No Human Can Match This
Manually stitching this together from regulations, guidance, and dozens of standards is slow, error-prone, and often inconsistent across projects.
Quality & Business Impact
More complete and defensible evidence plan; reduced risk of FDA asking "Where is the testing for X?" in an AI request.
What Cruxi Does
Runs full-document consistency checks across your submission (IFU, labels, Form 3881, comparison tables, risk files, test reports) to catch wording drift and contradictions.
Why No Human Can Match This
Humans skim; even great reviewers miss small wording differences across 200+ pages, especially under deadline.
Quality & Business Impact
Fewer inconsistencies for FDA to latch onto. Polished, "tells one story" submission quality.
What Cruxi Does
Maintains a live, cross-linked knowledge graph of your device: indications → risks → requirements → tests → results → labeling.
Why No Human Can Match This
A person might keep a spreadsheet or diagram, but manually updating every link with each change is not realistic.
Quality & Business Impact
Strong traceability story; easier answers to FDA questions like "Where do you show that risk X is mitigated and verified?"
What Cruxi Does
Simulates "what if" scenarios instantly – e.g., changing indication wording, removing a test, adding a feature – and shows regulatory/testing impact.
Why No Human Can Match This
Humans need hours or days to re-assess impact, read new guidance, and update documents each time.
Quality & Business Impact
Faster iteration, better decisions, less "accidental" scope creep into De Novo/PMA territory.
What Cruxi Does
Continuously learns from every project run through Cruxi (patterns of FDA questions, AI/RTA issues, testing expectations) and feeds that back into future recommendations.
Why No Human Can Match This
Individual consultants learn from their own cases; teams rarely aggregate and analyze hundreds of submissions' patterns at scale.
Quality & Business Impact
Institutionalized "collective experience" that keeps getting better instead of walking out the door with individuals.
What Cruxi Does
Scores draft sections against FDA expectations (clarity, completeness, alignment with guidance and predicates) before humans ever touch them.
Why No Human Can Match This
A human reviewer can give qualitative feedback, but cannot instantly benchmark every paragraph against thousands of prior examples.
Quality & Business Impact
Higher first-pass quality, fewer review cycles, more time for humans to focus on judgment, strategy and negotiation.
What Cruxi Does
Works 24/7 at full speed: scanning, checking, re-running analyses every time you tweak the device profile or add new data.
Why No Human Can Match This
Humans get tired, context-switch, go on vacation, and can only hold so much in working memory.
Quality & Business Impact
Stable, always-on quality baseline; reduced dependence on single "hero" reviewers.
The Punchline
Cruxi does what no human team can realistically do at scale or speed: mass-scanning regulations, codes, predicates, recalls, MAUDE events, and guidance in seconds and without getting tired.
But Cruxi is not a replacement for experts.
Cruxi + experienced human regulatory professionals = the highest quality 510(k) a company can produce.
You bring judgment, ethics, and real-world context. Cruxi brings exhaustive coverage, speed, and consistency. Together, you get safer devices, stronger submissions, and fewer expensive surprises.