Vikram Singh Email & Phone Number

Hyderabad, Telangana, India

• Interacted with clients to understand their needs and provided regulatory solutions to meet the project scope.
• Assisted in implementation of medical device QMS as per ISO 13485:2016 and 21 CFR 820. Conducted thorough gap analysis and provided remediation plans.
• Supported in aligning the technical documentation as per harmonized standards namely, ISO 14971, IEC 62304 and IEC 62366.
• Helped medical device start-ups to develop strategies for obtaining medical device regulatory approvals in countries like India and USA.
• Provided trainings on medical device regulations (EU MDR and US FDA) and implemented QMS as per ISO 13485 & 21 CFR 820.
• Liaised with multiple cross functional teams and successfully handled the projects.

Greater Minneapolis-St. Paul Area

Developed 3D designs of innovative and prospective ideas including applicators for different surgical applicationsParticipated in animal studies along with physicians as part of Design Validation testing for new productsWorked on developing and executing test protocols for new products for Design Verification Testing and Design Validation Testing Performed.

Ruston

Developed a non linear circuit based model for Brachiocephalic and Radiocephalic fistula vascular access geometries.Developed a flow chart representing various factors affecting the thrombosis formation in End Stage Renal Disease patients.Performed analysis on the factors affecting the failure of arteriovenous fistula.

Madison, Wisconsin Area

Implemented the spirometry algorithms on 20,726 patient data and analyzed the results which showed significant variation in the parameters with the numerical integration method used.Worked with an interdisciplinary team to record the impedance cardiography measurements on different chest locations.Assisted in developing a mechanism for feeding milk.