Translation and certification
Preparing translations and notarized documents for the selected procedure.
Our services
Medical device registration services
From documentation and production preparation to testing and registration support. Choose a service or tell us about your needs. We will help define the scope of work.
01 / SERVICE
Dossier amendments
Assessing changes, aligning documents and supporting dossier updates.
Learn more ↗02 / SERVICEQMS and ISO 13485
Quality management, operating procedures and preparation for an audit.
Learn more ↗03 / SERVICEManufacturing localization
Manufacturing operations, technical documentation and evidence of origin.
Learn more ↗04 / SERVICEManufacturing and assembly
Preparing manufacturing, assembly and quality control at partner facilities.
Learn more ↗05 / SERVICEMaterials and components
Preparing documentation on the intended use of materials and components.
Learn more ↗06 / SERVICERegistration in Russia
Documentation, testing and support for medical device registration in Russia.
Learn more ↗07 / SERVICERegistration in the EAEU
Dossier preparation and project support under Eurasian Economic Union rules.
Learn more ↗08 / PREPARATIONTechnical documentation
Source documents, technical specifications, operating documentation and the dossier package.
Learn more ↗Related needs
Additional services
ST-1 and registers
Preparing supporting evidence based on product origin and project requirements.
Public procurement
Developing technical requirements and aligning medical device information.
Tell us about your project
We will start with the device and existing documents, then agree on the scope, stages and expected outcome.
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