01Facility
Facility selection
A partner facility suited to the device design, production volume and quality management requirements.
Outcome: a facility suited to your device
Manufacturing
Manufacturing and assembly of medical devices
No facility of your own, or insufficient capacity? We arrange component manufacturing and device assembly at partner facilities and prepare production documents that are consistent with the registration dossier.
A description of the design and production volume is enough for the first conversation.
- 450+ projects of any complexity
- Direct contracts with laboratories
- One expert from start to finish
What you receive
From design to the first devices
Facility, process and production with documents for registration and supply.
02Preparation
Process and quality control
Process documentation, inspection and testing aligned with the registration dossier.
Outcome: process and quality control
03Production
Components or a finished device
Component manufacturing or device assembly with documents for registration and supply.
Outcome: manufactured devices
How we launch manufacturing
From design to the first devices, with documents for registration and supply.
01
Analysis
We review the design, volume and requirements.
Outcome: a production model02
Facility
We select a partner and prepare production.
Tooling, quality control, QMS03
Pilot batch
We manufacture and test the first samples.
We refine the manufacturing process04
Series production
Production of components or devices.
Documents for the dossier and supplyWhy 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.
What we can help develop
- Manufacturing individual components and assembling finished devices.
- Preparing technical and production documentation.
- Organizing quality control and necessary testing.
- Aligning manufacturing processes with registration documentation.
We select the facility, operations and timeline to suit the design and production volume after reviewing the device and documents.
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
Need a manufacturing facility?
Describe the design and volume. We will propose a manufacturing or assembly approach at a partner facility.
Discuss manufacturing ↗- 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