Alliance-Registro brings together test engineers, designers and regulatory specialists. We first understand how the device is built and how it works, and only then write the documents. That is why Technical specifications, operating instructions, test programs and the dossier say the same thing. The expert review has fewer reasons for remarks, and you lose fewer months going around in circles.
Relevant qualifications and practical experience in medical device development and testing, including work in state laboratories.
More than 10 years in regulatory affairs and more than 6 years in a testing laboratory. Started from scratch: worked in production, repaired and supplied medical equipment, wrote documentation, managed projects and saw them through to results. Built a team of like-minded professionals with extensive industry experience.
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.
We determine the appropriate registration route and scope of work based on the device and its intended market.
Medical device registration for circulation in the Russian Federation
Registration for medical device circulation in Eurasian Economic Union (EAEU) member states
projects over 10 yearsincluding complex devices and devices with a high potential risk class
They stay the same from one product to the next. That is why clients come back to us with their next projects.
Speak directly with the specialist managing your project and familiar with your device. Discuss documentation, testing and registration in one conversation. Your expert coordinates work with the manufacturer and laboratories.
We define the scope of testing and prepare test programs and methods. We select laboratories with the appropriate accreditation scope and align test results with the device documentation.
We agree on the scope, sequence and deliverables for every stage. Staged payments let you assess completed work and plan the next steps. You know what is ready and what remains to be done.
At every step you know what is ready and what comes next. We fix the scope of work after analyzing the device.
We study the device and the available documents and determine the requirements and the procedure.
Outcome: plan, timing and costWe write from scratch or refine the specifications, operating manual and labeling.
Outcome: a consistent set of documentsWe prepare test programs, select accredited laboratories and arrange inspection when required.
Outcome: test reportsWe combine documents and reports into one dossier, check the versions and submit to Roszdravnadzor.
Outcome: a dossier without discrepanciesWe answer the expert review requests and see the project through to the register entry.
Outcome: registration certificateProjects, manufacturing audits and team presentations. Insights into medical devices and the work behind registration.
Start with a single registration stage to assess our expertise before deciding whether to continue working together.
What would you like help with?
To start, an instruction manual or a short device description is enough. An engineer will analyze the device and send a list of documents for your procedure. We will help develop whatever is missing.
The timeline has two parts. We prepare documents and testing in parallel, so this part depends mainly on how ready your materials are and on laboratory workload. The expert review and consideration at Roszdravnadzor follow the deadlines set by Government Decree No. 1684. After analyzing the device, we provide a plan with timing for each stage.
We have registered devices of any complexity: from dressings and bracket systems to anesthesia units, 2,000-liter sterilizers, X-ray equipment and implants. Our head worked as a test engineer at VNIIIMT, an institution subordinate to Roszdravnadzor. If your device is new to us, we will say so right away and explain how we will close the gaps.
The cost depends on the risk class and how ready the documents are. Guide prices by class are in the price list, and we name the exact amount after analyzing the device. Payment is made in stages, and you pay for the finished result of each step.
Answering expert review requests is part of our work. We analyze the remark, check it against the technical materials and prepare a reply or clarifications in the documents. We see the project through to the Roszdravnadzor decision and check the register entry.
Ask an engineer directly. We will answer to the point, with your product in mind.
