Dmitry S.

Experience

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  DONA-M LLC

  Feb 2011 - now

  Main job duties:- Implantable medical device market analysis;- Analysis of clinical experience of implantable medical devices own and concurrent manufacturing in Russian and World practice;- Projects PR;- Medical science literature and technical documentation analysis;- Knowledge of main ISO, GOST and ASTM standards for medical devices design and manufacturing;- Design of technical documentation for medical devices;- Project team management;- Search for suppliers and purchases of components and materials for medical use;- Search for suppliers and purchase of production and testing equipment;- Negotiating and business correspondence with partners and customers, including with foreign;- Organization of conclusion of contracts and agreements with partners and customers, including foreign ones;- Preparation of documents for medical devices certification;- Organization of technical and acceptance tests of medical devices and medical materials;- Organization of production of prototypes of medical devices;- Organization of production of serial parts of medical devices;- Organization of technical testing of medical devices and medical materials;- Organization of quality control of manufactured medical devices;- Launch manufactured medical devices.Main achievement:- Agreements have been concluded on clinical testing of implantable medical devices: left and right ventricle support devices-the stream Cardio Complex (BiVAD) on a commercial basis.- Successful familiarization of clinical specialists with the basics of using a medical device;- Collection of statistics on the clinical use of a medical device is organized.- Developed parts, organized production of prototypes of implantable medical device: Catheter micro-pump (Endovascular VAD);- Developed a method for testing a medical device and testing equipment; Show less Main responsibility:- Analysis of scientific literature and technical documentation on medical devices and medical materials;- Development of technical documentation (TK, TU, CD, TD, re) for medical devices (including active implantable medical devices);- Team management on projects;- Search for suppliers and purchase of components and materials for medical devices, including abroad;- Search for suppliers and purchase of production and testing equipment;- Preparation of documents for registration of MI in Roszdravnadzor;- Organization of production of prototypes of medical devices;- Organization of production of serial units of medical devices;- Organization of technical tests of medical devices and medical materials;- Organization of quality control of manufactured medical devices;Main achievement:Successful comprehensive participation in projects for the development, production, clinical trials and market launch of high-tech implantable medical devices:- Devices for supporting the left and right ventricles of the heart-the "stream Cardio" Complex (BiVAD).In particular:- Successful development of medical device components that were integrated into the final product;- Established supply of components and materials for production;- Purchased production, Assembly and testing equipment;- Technical documentation released;- A set of tests was carried out;- Conducted clinical trials;- Developed methods and guidelines for clinical use;- The product has been successfully certificated;- Successful technical and preclinical tests of prototypes of implantable medical devices were conducted: Children's blood pump (Pediatric VAD).- Successful clinical trials of an individual implant for reinforcement of an ascending aortic aneurysm developed in-house;- Gained extensive experience in the development and production of implantable products for traumatology and orthopedics. Show less Participation in projects for the development and production of high-tech implantable medical devices: the AVK - N Left Ventricular Assist Device (LVAD), BiVentricular Assist Device(BiVAD):- Analysis of scientific literature and technical documentation on medical devices and medical materials;- Development of technical documentation for medical devices (including active implantable medical devices);- Search for suppliers and purchase of components for medical devices, including abroad;- Conducting technical and acceptance tests of medical devices and medical materials;- Preparation of reports on research and development;- Commissioning of finished medical devices. Show less

  • Associate Director

    Jan 2020 - now

  • Head of science and technical department

    Jan 2018 - Jan 2020

  • Engineer/researcher

    Feb 2011 - Jan 2018
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  New technology of health LLC

  Jan 2015 - Dec 2017

  Head of new development department

  Main responsibility:- Formation of the project concept;- Market analysis of similar medical devices;- Conducting a PR campaign for the project;- Team management on the project;- Development of technical documentation for medical devices (including gas exchange systems with blood) and test equipment;- Search for suppliers of components for medical devices, including abroad;- Search for suppliers of production and testing equipment, including abroad;- Formation of technical specifications for the purchase of production and testing equipment, including abroad;- Conducting negotiations with partners and clients, including foreign ones;- Preparation of reports on research and development.Main achievement:Project management for the development of extracorporeal blood oxygenation system (ecmo) - Therapeutic oxygenation device " TAO":-A successful analysis of the domestic market has been made, resulting in a real need for a device on the territory of the Russian Federation;- Developed technical documentation for a patentable device;- Contracts were signed with foreign and domestic suppliers of ecmo system components; Show less

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  Federal State Budgetary Institution “Academician V.I.Shumakov Federal Research Center of Transplanto

  Feb 2015 - Jun 2015

  Senior technician

  Main responsibility:- Commissioning of medical devices and testing equipment;- Control of operating parameters of medical devices during the experiment;- Control of physiological parameters of experimental laboratory animals;- Maintenance therapy for laboratory animals.Main achievement:Successful preparation and conduct of preclinical tests of high-tech implantable medical devices on laboratory animals (large and small cattle).