Shraddha Chauhan

About Shraddha Chauhan

Currently, at Clinical Centre of Excellence of Danaher corporation I am functional in preparing clinical trial related documents of medical devices and IVDs from five different diagnostics companies such as Radiometer, Beckman Coulter, Leica, Hemocue and Cepheid- At safety, surveillance and reporting unit of Radiometer, I work collaboratively with global team to prepare regulatory documents such as Clinical study report, Clinical study results report, Summary of clinical study, Investigators brochure for medical devices and IVDs per FDA/EU MDR regulations- Previously at Tata Elxsi, I helped my team to prepare regulatory docs for global medical devices clients, defining the strategic approach for medical devices to leverage the transition to European Medical Device Regulation (EU MDR), write and review content of Clinical Evaluation Plan and Report, Post market clinical follow ups (PMCF) Plans and report, Post Market Surveillance (PMS) plan and reports, Technical Documentation, General Safety and Performance Report (GSPR), Device Classification, Biocompatibility as per EU MDR and European Medical Device Vigilance System MEDDEV 2.7.1 Rev 4, Guided team for systematic literature review to establish state of the art of current medical devices, evaluation of product specific literature and data for similar competitors and alternative devices across wide range of therapeutic areas- During my tenure at startup business incubator SINE-IIT Bombay, I was functional in start-up incubation process beginning from the idea/product/technology evaluation to technical support during incubation- My research expertise is on design and fabrication of different geometries of optical fibers to enhance the sensitivity of fiber-optic sensors. During my PhD tenure I was involved in synthesis, characterisation and application of noble metal nanoparticles of different geometries for sensing extremely low concentration of bio/chemical compounds. I have learned electron microscopy and harboured immense interest in same.Specialties: Fabrication, Synthesis and Characterization of metal nanoparticles, Surface chemistry, Surface functionalization, thin film deposition, MEMS, Electron Microscopy.

Experience

1. Medical Writing Specialist - Clinical & Medical Affairs

   Danaher

   Mar 2024 — Present

Education

• Matruchhaya

  Science

• Indian Institute of Technology (Banaras Hindu University), Varanasi

  M.Tech., Biomedical Engineering

• Indian Institute of Technology, Bombay

  Ph.D, Nanotechnology and nanoscience

• CCET, Saurashtra University

  B.E., Biomedical & Instrumentation Engineering

Skills

• Matlab
• Scanning Electron Microscopy
• Fluorescence Spectroscopy
• Tem
• Microfabrication
• Nanomaterials
• Characterization
• Spectroscopy
• Materials Science
• Biomedical Engineering
• Transmission Electron Microscopy
• Nanotechnology
• Nanoparticles
• Thin Films
• Biomaterials
• Optical Biosensors
• Nanofabrication
• Microscopy
• Sensors