NEEDFORMED LLC – Your expert regulatory consultant for medical device registration in Russia, Commonwealth of Independent States (CIS) and Eurasian Economic Union (EAEU) countries.

We help manufacturers and distributors bring their products to market across Russia, the Commonwealth of Independent States (CIS), and the Eurasian Economic Union (EAEU). We accelerate market entry while reducing regulatory risks, delivering the most efficient and cost-effective solutions for our clients.

We develop and implement Quality Management Systems compliant with the Interstate Standard (CIS Standard) GOST ISO 13485, which has been implemented as the Russian National Standard since June 1, 2018. This ensures the highest standards in medical device manufacturing and maintains stringent quality controls at all operational stages.

Additionally, we offer support in intellectual property, product certification and declaration, as well as obtaining licenses for medical activities and the maintenance of medical devices.

• Flexibility – we adapt to our clients’ time zones and working schedules;
• Security – we utilize corporate VPNs and data encryption to ensure full confidentiality;
• Transparency – we document all work stages and provide comprehensive reporting.

We operate on a «Cloud-Based Service» model: Our team works entirely remotely without physical office constraints, leveraging advanced digital technologies for seamless collaboration.

This enables us to:

• 24/7 Regulatory Inquiry Support;
• Engage the best regulatory experts from different regions;
• Reduce expenses and offer competitive conditions.

• Online Meetings – we conduct consultations and meetings via secure platforms (Yandex.Telemost, Zoom, Microsoft Teams, etc.);
• Offline Meetings in Moscow and St. Petersburg – we organize in-person meetings to discuss your project;
• Digital Document Workflow – we operate through cloud services with e-signatures for full legal validity;
• Multilingual Support – communication in Russian, English, and Chinese.

We have proved that the quality of services depends not on the office address, but on the team expertise!