Deepika Mohankumar Email & Phone Number

> Gap analysis and Remediation of Risk Management activities and QMS related processes for the global market including drafting the plan, hazard analysis, FMEA etc. > EUMDR remediation activities for medical devices in cardiology, orthopaedics, etc.> MDR 2017/745- Trace matrix, Risk management assessment/checklist, Standards assessment, Gap analysis, StED.

Bengaluru Area, India

>Prepare and maintain quality documents and SOPs in accordance with Detailed Work Instruction>Prepare 510k for products seeking market approval from the US FDA>Provide technical and documentation support for clients relating to quality management including but not limited to risk assessment, risk analysis and hazard analysis, product catalogue, device.

San Francisco Bay Area

• Review complaint records and apply standard operating procedures to determine MDR reportability to the FDA
• Triaging to decide the appropriate mode codes and assess the risk, severity and adverse health outcomes of a complaint
• Provide clinical and technical support in response to inquiries from physicians, health care professionals, patients and field staff
• Receive medical device complaints, create, investigate and review records
• Prepare MDRs as appropriate to the FDA, maintain quality documents
• Coordinate the resolution of complaints with the field and ensure timely investigations are performed

San Francisco Bay Area

• Receive medical device complaints, create, investigate and review records
• Prepare MDRs as appropriate to the FDA, maintain quality documents
• Coordinate the resolution of complaints with the field and ensure timely investigations are performed

• Musculoskeletal injuries in endoscopists – A kinematic analysis
• Estimated the motion ranges of endoscopists while they performed simulated endoscopy, to determine the effect of extreme range of motion and understand the link between endoscopic maneuvers and musculoskeletal injuries
• The different factors such as range of motion, procedure difficulty, orientation and years of experience were considered
• Duties included recording of wrist orientations of endoscopists using a motion tracking sensor, classification of the kinematic data into different ranges using Matlab, statistical analysis to quantify the motion ranges
• Preparation of scientific manuscript for leading journals
• Observed endoscopic procedures at Mayo Clinic, Scottsdale to understand the challenges faced by surgeons

Master Of Science (M.S.), Bioengineering And Biomedical Engineering, 3.5

Activities and Societies: Indian Students Association, Ichos music band, KalaShrushti choir, Spicmacay

Bachelor Of Engineering (B.E.), Bioengineering And Biomedical Engineering