Ing. Somashekara Koushik Ayalasomayajula

- Pre-Submission review of technical documentation to Notified Bodies for medical devices and ancillary therapeutic and /or diagnostic products - Deployment, documentation and maintenance of QMS acc. to ISO 13485, MDR and MDSAP requirements for clients - Development of risk management strategies, procedures and files - Execution of regulatory compliance audits for clients - Training of employees in relevant QMS and technical standards - Team management

- Pre-Submission review of technical documentation to Notified Bodies for medical devices and ancillary therapeutic and /or diagnostic products - Development, documentation and implementation of QMS and related support activities for clients - Development and document regulatory files for medical devices and ancillary products - Development of risk management strategies, procedures and files - Implementation and validation of processes - Execution of regulatory compliance audits for clients

Assistance in technical documentation. Investigation of new materials for primary packaging of medical devices. Process optimization of hollow fiber spinning

Ageing of Ultra filtration membranes. Understanding the effects of various parameters on ageing behavior of hollow fiber ultra filtration membranes and Validating the technique of accelerated ageing to investigate the shelf life of a haemodialyzer.

Modeling of hemodialysis: Understanding urea kinetics and building a numerical model for 1 and 2 compartment hemodialysis system with the aid of MATLAB. Verification of developed model with standard models available.

Understanding the basic designing of steam turbine, diagrammatic representation of the velocity triangles and knowing in detail about the various parts of steam turbine. Fabricating various parts of steam turbines using various machines and processes involved followed by assembly of parts and then balancing of forces acting on the rotor of the steam turbine.

- Creation and review of drawings - Write CNC codes to facilitate the production of components - Service and maintenance of production machines

Specialised in 'Applications of Polymers in Health Care and MedTech Sector' Subjects: Polymer Materials, Polymer testing, Polymer physics & Rheology, Injection Molding, Extrusion, Design Of Experiments (DOE), Mold design, Control Engineering and Process Simulation

Focus on Product Development, Material sciences and Quality Engineering.