01Engineer
An engineer leads your project
One specialist knows your device, answers your questions and coordinates the manufacturer and laboratories.
Outcome: one contact for the whole project
About us
Understand the device. Substantiate the decisions.
Alliance-Registro brings together test engineers, design engineers and medical device registration specialists. We first understand how a device is built, then prepare its documents. This leaves fewer grounds for comments during expert review.
A device description or instruction manual is enough for the first conversation.
- 450+ projects of any complexity
- Direct contracts with laboratories
- One expert from start to finish
How we work
Three principles we follow
These guide every project, from the first conversation to the outcome.
02Stages
Work and payment in stages
We agree on the scope, deliverable and price of each stage before starting.
Outcome: you can see what is complete
03Documents
Documents tailored to your device
We do not simply use a template. The description, technical specifications, manual and test programs are written for the device's design and intended use.
Outcome: fewer expert review comments
Working with us
One clear route for any task, from the first conversation to the outcome.
01
Conversation
We review the task and materials with you.
No obligation02
Plan
Stages, deliverables and the cost of each.
Staged payments03
Work
An engineer manages the project and answers questions.
You can see what is complete04
Outcome
Documents, a dossier or a registration certificate, depending on the task.
You decide whether to continueWhy 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.
The experience behind our team
Our team includes specialists with experience in testing laboratories, including state laboratories, and graduates of Bauman Moscow State Technical University and MEPhI. The company head spent more than six years working as a medical device test engineer in a state laboratory.
We examine intended use, design and operating principle. We compare specifications, documentation and verification methods so that the project's information is consistent.
Engineering work and support
- We develop or refine technical and operating documentation.
- We determine testing scope and prepare programs and methods.
- We coordinate work with the manufacturer and laboratories.
- We prepare the registration dossier and help address review comments.
- We account for market circulation requirements and public procurement needs.
Your project is managed by an expert who knows the device. We agree on the scope, deliverables and payment terms before work begins.
Assess our expertise at the first meeting
Bring a device description and the documents you have. We will review the task with you, discuss similar projects and suggest a starting stage.
Sharing practical experience
Presentation at the “Military Medicine of the 21st Century” conference
Руководитель компании Павел Аряшев рассказал об особенностях регистрации медицинских изделий для гражданских задач и военных нужд.
Presentation, photo and program ↗Our partners
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.
Tell us about your device
At the first meeting, we will review the task and source materials and explain where to start.
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