Manufacture of medical devices

Enterprise localization format

Organization of production on the territory of Russia (separate)

Equipment cost estimation and procurement;

Procurement of materials and components;

Drafting technical specifications for production;

Equipment installation and production line commissioning;

Development of technological processes;

Development of technical and operational documentation;

Staff selection and training for medical device production;

Product registration in accordance with the requirements of Government Decree No. 1684;

Enterprise launch;

Obtaining the Ministry of Industry and Trade conclusion under Government Decree No. 719.

Contract production in Russia

Preparation of a cost estimate per unit of production;

Drafting technical specifications for production;

Provision of production facilities with ISO 13485 certification;

Provision and training of staff for medical device production;

Product registration in accordance with the requirements of Government Decree No. 1684;

Obtaining the Ministry of Industry and Trade conclusion under Government Decree No. 719.

Contract manufacturing in China, India, and the CIS.

Search for an enterprise with ISO 13485 certification;

Drafting technical specifications for production;

Preparation of a cost estimate per unit of production;

Preparation and signing of the production contract;

Arrangement of a personal meeting with the manufacturer's representatives;

Development of technical and operational documentation;

Production of a pilot batch;

Import of products for testing and trials;

Product registration in accordance with the requirements of Government Decree No. 1684;

Launch of serial production;

Logistics organization.

Team

Heads of the contract manufacturing department

Klimov Vladislav Yurievich

Executive Director

Questions

Frequently Asked Questions

When organizing production, we build and equip your own factory turnkey, while with contract manufacturing, we produce your product at our already existing and certified facility.

The conclusion under Decree No. 719 confirms your product's status as a Russian-made good, providing preferential treatment in government procurement under 44-FZ and access to state support measures.

We work only with enterprises that hold ISO 13485 certification, personally visit the site to audit the facility, and oversee the production of a pilot batch before mass production begins.

The timeline ranges from 6 to 12 months for contract manufacturing in Russia and from 12 to 24 months for setting up your own factory from scratch.

No, we handle all operational processes entirely, but we involve you in approving the technical specifications and accepting the pilot batch to ensure the product meets your expectations.

Advantages

What will you get?

/01

Turnkey production without capital expenditures

You don't need to purchase equipment, rent workshops, or hire staff — we provide our certified facility (ISO 13485) and trained personnel, and you receive the finished product.

/02

Localization in Russia with government support

We ensure obtaining the Ministry of Industry and Trade conclusion under Government Decree No. 719, which confirms Russian manufacturer status and grants access to preferential treatment in government procurement and state subsidies.

/03

Full turnkey legal and regulatory support

We handle all stages: from developing technical documentation and registration under Government Decree No. 1684 to organizing logistics and launching serial production.

/04

Reducing time-to-market by up to 40%

Thanks to ready-made infrastructure, streamlined processes, and deep expertise in medical device regulation, we launch production significantly faster than building your own factory from scratch.

/05

Minimizing risks when working with foreign manufacturers

We personally audit facilities in China, India, and the CIS for ISO 13485 compliance, oversee pilot batch production, and organize logistics, eliminating defects and supply delays.

Advantages

Why us?

Expensive? It's an investment in your profit and independence

Launching your own production requires capital investments in equipment, rent, personnel, and registration. Mistakes at any stage can cost millions. Our services pay off through proper planning, no downtime, and timely product market entry.

We can do it ourselves

You can, but how long will it take? Finding suppliers, auditing sites in China or India, drafting technical specifications, equipment commissioning, completing Decree No. 1684 and No. 719 — each stage requires narrow expertise. One mistake in documentation — and the launch is delayed by six months. We have already gone through this path hundreds of times.

There are cheaper offers

Cheaper means someone is cutting corners on quality. We offer a comprehensive turnkey service: from finding a manufacturer and purchasing equipment to obtaining the Ministry of Industry and Trade conclusion. No hidden charges for revisions, additional testing, or urgent site visits. You pay only for the result.

Transparency

Guarantees and trust

Turnkey result guarantee

We take full responsibility for the final outcome: from the operational functionality of the production line to obtaining the registration certificate under Government Decree No. 1684 and the Ministry of Industry and Trade conclusion under Government Decree No. 719. If any difficulties arise at any stage, we resolve them.

Transparent reporting

We provide regular project status reports: photo reports from production sites (including overseas), certificates of completed work, cost estimates, and procurement schedules. You always know at what stage your order is and where the funds are going.

Confidentiality

Full protection of your trade secrets, design documentation, and technological solutions. We operate under an NDA (non-disclosure agreement), guaranteeing the security of your intellectual property rights and product patent purity.

Order a call from an expert and start producing your product as soon as possible.

Feedback

Submit a request

Contacts

Our contacts

Office in St. Petersburg

St. Petersburg, st. Mozhaiskaya, 17

ElibriumCEO@yandex.ru

+7 (911) 903-04-84