English
- Assistance in obtaining permits for the import of samples of medical devices.
- Organization of visits by engineers and doctors for the purpose of conducting tests.
- Identification of regulatory documents for medical devices and preparation of information on regulatory documentation for medical devices.
- Writing technical documentation, correction of operational documentation, development of technical specifications (TS), notifications of changes in TS, completion of TS notifications.
- Making changes to the registration certificate.
- Making changes to the registration dossier.
- Duplicate of the registration certificate.
- Replacement of the registration certificate form.
- Conducting technical, toxicological, EMC, and SIMN tests.
- Conducting clinical trials in the form of data analysis and evaluation.
- Selection of interchangeable medical devices, writing comparison protocol of technical characteristics.
- Writing requests to authorized bodies.