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Trusted by 200+ MedTech teams across the globe

FDA Regulatory Services for Medical Device Manufacturers

Complizen provides guidance across device classification, 510(k) submissions, U.S. registration, and post-market compliance — fixed prices, defined deliverables, on every engagement.

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Fixed price, quoted up front
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Where are you right now?

Your path

2 services · 10–14 weeks

Find the predicate and build the 510(k).

In our experience, most Additional Information requests trace back to a weak predicate argument, not a weak device. We put the comparison in writing and agree it with you before drafting starts.

  1. 01Regulatory strategySubstantial-equivalence argument and testing plan2 weeks
  2. 02510(k) submissionFull eSTAR built, filed, and AI responses handled8–12 weeks
See 510(k) submissionTesting already done? We price strategy on its own.

Our services

All FDA services

Expert regulatory support at every stage — from initial registration to ongoing compliance management.

Stage 01

Establish US presence

US AgentA named US contact of record who answers when FDA calls, and forwards nothing into a void.$1,000 a yearService detailsEstablishment registrationOwner/operator account, annual fee, and your facility correctly on the FDA register the first time.$500Service detailsDevice listingEach device tied to the right product code and regulation, so distributors and customs stop asking questions.Included in registrationService details
Stage 02

Get to market

Regulatory strategyClassification, pathway, and a shortlist of predicates you can actually defend — with the testing that follows from them.$3,000Service detailsMost requested510(k) submissionThe complete eSTAR built, formatted and filed — and every Additional Information request answered inside the original price.$11,000 to $20,000Service detailsClass I device listingFor devices exempt from 510(k). The listing built under the right product code, with a label review against 21 CFR Part 801 included.$2,000Service details
Stage 03

Stay compliant

Label reviewLabels and IFUs checked against 21 CFR Part 801 before you print. Labeling is a common cause of import detention.Price on requestService detailsUDI submissionYour device records built and published in FDA's GUDID database, under the right device identifier.Price on requestService detailsRetainerRegulatory advisoryA named regulatory lead who already knows your portfolio, answering within one working day. Monthly, not per project.From $950 a monthService details

Prices are for a single device and are confirmed in writing before work begins. FDA user fees, testing-laboratory costs and translation are passed through at cost and quoted separately.

How it works

From free analysis to FDA, in four steps.

  1. 1

    Free pathway analysis

    Tell us about your device. We will review it and analyze its pathway, then come back with the next steps.

  2. 2

    Determine the class

    We confirm the class, and the product code.

  3. 3

    Build the file, or register

    If your device needs a 510(k), we build the submission. If it is Class I and exempt, there is no submission to build — we register the establishment and list the device instead.

  4. 4

    Submit to FDA

    We file, and get you there in about half the time it takes a first-time filer working alone.

An experienced regulatory reviewer signs off on the completed file before anything reaches FDA. Additional Information responses are included in the original fixed fee.

Ángel Enríquez, EmboaMed — 510(k) submission services
“Complizen turned what felt like a four-month scramble into a focused sprint. The expert review gave our team confidence we couldn't have built submitting alone.”
Ángel Enríquez, Ph.D.Founder & CEO, EmboaMed
Melissa Hall, Statera Consulting — FDA regulatory strategy
“The regulatory strategy work clarified the right pathway in a single conversation. It paid for itself ten times over before we wrote a single section.”
Melissa HallFounder & Principal Consultant, Statera Consulting

Still not sure which one you need? Start with the free check.

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