Profile Details

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USD 20 /hr

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Hire Pragatheeshwaran N.

India

USD 20 /hr

Four plus years of hands-on working experience in Medical device PMS complaints handling, vigilance and RPA (Uipath )

Profile Summary

Experienced in Medical device Post Market Surveillance (PMS) and process improvement. Familiarity with USFDA (21CFR Part 820, 806 and 803), QMS (ISO 13485:2016), ISO 14971, Complaint management, Complaint investigation, Risk analysis, CAPA initiation Complaint closure and submission of MDR.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Product Design
• ☆ CAD & 3D Modeling

Services

• Research
• Consulting
• Product Development

Research Market Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Product Evaluation, Prototyping

Work Experience

Quality analyst engineer

Cyient Limited

May 2022 - Present

Quality analyst engineer - PMS

HCL Technologies Ltd.

April 2018 - May 2022

Education

B.E

Parisutham Institute of Technology and Science

August 2013 - June 2016

Certifications

• Certification details not provided.