Deepika Mohankumar Email & Phone Number

Bengaluru, Ka, In

> 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 file compilation, Design verification and validation, Design inputs assessment, CAPA, Usability engineering > Ensure compliance to international standards - ISO 13485, 14971, 16061, 10993, IEC 62304, 62366, 60601 etc.> Review design documents and other deliverables to ensure quality and regulatory compliance> Update review records to make sure all defects are captured and ensure traceability and quality> Provide relevant technical and informative trainings to the team> Leading the team for process improvement activities> Taskforce activities for Regulatory knowledge sharing

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 manual, international standards >Assist in documentation for CE mark approval such as gap analysis, CERs etc.>Creating technical presentations and training materials for the team

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•Technical trainer for the staff including cardiac anatomy, physiology and cardiac implantable products’ training for new hires as well as cross-trainer for department updates•Creating and managing trends, aging report, severity review and risk assessment reports

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 •Co-authored an abstract titled “Sequential Analysis of the Ergonomics of First Year Gastroenterology Fellows with Simulated Endoscopy to Assess Effect of Practice on Range of Motion: An Attempt to Reduce Musculoskeletal Injury During Endoscopy” which was accepted for DDW 2013 conference

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