Project scope and costs
Service pricing. A clear estimate.
The starting cost depends on the risk class of the device. We fix the final budget after analyzing the device and documents. Payment is made in stages, and you pay for the finished result of each step.
A device description and existing documentation are enough for an estimate.
Under Russian national rules
Registration in Russia
Starting project prices by risk class. The estimate specifies the included work and testing, official fee and translation costs.
Under EAEU rules
Registration in the EAEU
Starting project prices by risk class. The estimate specifies the included work and testing, official fee and translation costs.
How we calculate
What is included and what is charged separately
Your device-specific estimate sets out the exact scope and costs. The general approach is as follows.
Included in the project work
- Device analysis and a work plan with stages and timings.
- Development or refinement of technical and operating documentation.
- Test programs, laboratory selection and test report review.
- Dossier assembly, submission and responses to expert review requests.
Usually charged separately
- Testing in accredited laboratories under a direct contract, with no markup from us.
- Government fees and expert review charges.
- Document translation and notarization.
- Manufacturing inspection, where required by the procedure.
No markup on third-party services. Testing is done under direct contracts with laboratories. You pay them directly at the laboratory rates, and we add nothing on top. Our work is shown as a separate line in the estimate.
Individual assessment
Documentation, QMS and manufacturing
The cost of documentation, QMS implementation, localization, manufacturing and assembly depends on source materials and scope. We prepare an estimate for the specific task.
Dossier amendmentsDossier amendments: from procedure assessment to an updated register entry.Learn more ↗QMS and ISO 13485Assessment, documentation and audit preparation.Learn more ↗LocalizationThe Ministry of Industry and Trade register, ST-1 and dossier amendments.Learn more ↗Manufacturing and assemblyPartner facility, process and production.Learn more ↗
Why clients choose us
Registration without detours and lost months
We do not sell template packages. Every project starts with analyzing the device, so the documents pass the expert review and cause no problems after registration.
We read the dossier like an expert
Our team includes test engineers. They find discrepancies before submission, not after Roszdravnadzor remarks.
We write documentation from scratch
No specifications or operating manual? We will develop them. Have them but with errors? We will refine them so that everything matches.
One expert from start to finish
One specialist runs your project. They coordinate with the manufacturer and laboratories and are always available.
Devices of any complexity
From dressings to anesthesia units, X-ray equipment and implants. More than 450 projects in 10 years.
Trusted by
Chosen by those who cannot afford a mistake in the dossier
Developers of devices for military medicine, defense enterprises, Russian plants and manufacturers from China, Türkiye, Korea and Germany. Below are our partners and signed and sealed letters of appreciation.
Appreciation from the Burdenko Main Military Clinical Hospitalfor professionalism and contribution to the domestic medical industry
Talk at the Military Medicine of the 21st Century conferencethe conference is organized by the S. M. Kirov Military Medical Academy
Letters from VIKor, SigmaPharm, Implant Engineering and many othersThis list grows with every project. Signed and sealed letters are collected below on this page.
Our partners
Get an estimate for your device
Send a device description and existing documentation. We will clarify the work required and propose a plan with stages and costs.
Discuss your project ↗- 15+engineers and specialists
- 10+ yearsof experience among our leading specialists
- 450+projects of any complexity
Have questions or need a consultation?
What would you like help with?
- We will look into your task and suggest where to start
- After the review we send a plan: stages, timeline and cost
- You talk directly to the specialist who runs the project