For medical-device manufacturers in any country
From zero to a ready ISO 13485, CE and FDA dossier, in your own language
Answer a few simple questions about your company and product. You see the registration path, the documents and tests you need, and a fixed price right away. Quality-system documents come in your language and English; CE and FDA files in English.
Your path in six steps
The first two steps are free. You see the fixed price before paying anything.
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1 Free
Tell us about your company and device
A short questionnaire: device type, body contact, sterility, software and target markets.
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2 Free
Path, readiness score and price
Documents and tests per path, your readiness score and a fixed project price, straight away.
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3 Project start
Complete document list
With the deposit, the master document list with standard numbering and a preview of every document opens.
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4
Your data, our writing
Simple forms for test results and data; we write the procedures, forms and technical file.
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5
Expert review
A regulatory specialist checks the documents against your data and finds gaps before submission.
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6
Final delivery
After full payment: editable Word files and PDFs ready for signature, in your language and English.
You don't need to know how to write the documents
Every test and data type has a short form: laboratory, standard, sample size, acceptance criteria, result and the original report. You give the real data; we write it the way FDA, a Notified Body or an ISO auditor expects.
We never invent test results or clinical data. Every number in the final documents comes from your original reports.
What you enter
What we build
- Test summary in the biocompatibility section of the 510(k)
- The matching row in the GSPR checklist of the CE technical file
- A reference in the ISO 14971 risk management file
- A controlled record in the quality system
Write your company name once
Every document is built from the master document list. Each page header carries the document number, revision, preparation date, revision date and page number, and each page ends with signature boxes for prepared, reviewed and approved.
The Persian version uses the Persian calendar; the English version the Gregorian one.
Problems we see with the usual options
From QMS software, AI tools for FDA submissions and traditional consulting, and what we do differently.
| Common problem | Our approach |
|---|---|
| Prices hidden behind “contact sales”, multi-year contracts, yearly increases | A fixed price per path before you start; no long-term contract |
| Months of onboarding and mandatory training sessions | Start in minutes with one questionnaire |
| They assume you have a regulatory team that knows which documents are needed | We build the full document list from the standards and your device |
| English only, built for US and European companies | Guidance and QMS documents in Persian and English; more languages coming |
| AI tools assume your test reports already exist | We start from zero: quality system, standards and test plan, then the dossier |
| In-app editors weaker than Word, inconsistent formatting | Controlled Word output with the same header and signatures on every document |
| Generic templates, or a previous client's documents with the name changed | Every document is built from your own company and device data |
| FDA refuse-to-accept over a missing section or inconsistent text | Required sections and consistency checked before submission |
See the price before you start
The exact price depends on your country, company size and device class, and is shown in the free assessment. Two instalments: 60% to start, the rest before the final files are delivered.
ISO 13485
Complete bilingual quality system
from 1,200 USD
CE under MDR
Technical documentation and clinical evaluation
from 700 USD
FDA 510(k)
510(k) submission ready to file
from 5,000 USD
FDA Registration
Establishment registration and listing
from 900 USD per year
Government, Notified Body and laboratory fees are separate and paid by you directly; for FDA fiscal year 2027, for example, the 510(k) review fee is $28,653 ($7,163 for a small business) and annual establishment registration is $13,785.
See how close you are to market
Free assessment: the path for each market, documents and tests required, and your readiness score, with no commitment.