Preparation and comprehensive support of the process of registration of medical devices and software for medical purposes

Description

Preparation and comprehensive support of the process of state registration of medical devices and medical software:

• Ensuring the conduct of preclinical / clinical studies of medical devices, medical software, including:
- Expert assessment of the possibilities of conducting and organizing technical tests: selection of laboratories, preparation of an application and a set of documents required for testing.
- Expert assessment of the possibilities for conducting and organizing toxicological tests: selection of laboratories, preparation of an application and a set of documents required for testing.
- Expert evaluation of the possibilities of conducting and organization of clinical trials: selection of clinics, preparation of an application and a set of documents necessary for conducting trials.

• Works and services for the preparation (development, revision) of documents to ensure the conduct of preclinical / clinical studies, including:
- Development, revision of technical conditions for a medical device in accordance with the requirements of GOST 2.114-2016 “Unified system for design documentation. Technical conditions.
- Development, revision of the manual for the medical device in accordance with the requirements of GOST 2.610-2006 “Unified system for design documentation. Rules for the implementation of operational documents.
- Development, improvement of the risk management file in accordance with the requirements of GOST ISO 14971-2011 “Medical products. Application of risk management to medical devices.
- Development, revision of the qualification test report in accordance with the requirements of regulatory documentation.
- Development, revision of the test program for technical tests in accordance with the requirements of the order of the Ministry of Health of Russia dated January 9, 2014 No. 2n “On approval of the procedure for assessing compliance of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices”.
- Development, refinement of the test program for toxicological tests in accordance with the requirements of the order of the Ministry of Health of Russia dated January 9, 2014 No. 2n “On approval of the procedure for assessing compliance of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical products”.
- Development, revision of the clinical trial program in accordance with the requirements of the order of the Ministry of Health of Russia dated January 9, 2014 No. 2n “On approval of the procedure for assessing compliance of medical products in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices”.
- Development, revision of other technical documentation (design, technological, software and operational) for a medical product in accordance with the requirements of the standards required for conducting technical, toxicological and clinical tests, and / or for the state registration of a medical product.
• Organizational and methodological assistance in obtaining a registration certificate, including:
- Collection / revision / development of the necessary technical documentation for a medical product, technical, toxicological and clinical test protocols in order to form a registration dossier for the state registration of a medical product;
- Preparation and submission of the registration dossier to the regulatory authorities for the purpose of state registration of the medical product;
- Submission of subsequent reports and notifications to the regulatory authorities (elaboration of responses to the comments of the expert organization, submission of the notice of the beginning of clinical trials, submission of the results of clinical trials, preparation of the necessary set of documents for the ethics committee, etc.).