Athikesavan R

Medical Devices Regulatory Auditor and Product Assessor

Role
Medical Device Assessor at SGS
Location
Chennai, TN, IN
LinkedIn followers
500 followers
Healthcare & Human ServicesView LinkedIn profile

About Athikesavan R

Regulatory Affairs professional with 25 years experience in Medical Device Industries…

Experience

  1. Medical Device Assessor

    SGS

    Apr 2024 — Present · BE

    Notified Body

Education

  • University of Madras

    Bachelor of Business Administration

  • State Board of Technical Education, Tamil Nadu

    DME, Mechanical Engineering,

    1988 — 1991

Skills

  • Iso
  • Fda
  • Iso 10993
  • Us Fda 21 Cfr Part 820
  • Regulatory Submissions
  • Iso 14971 Risk Management for Medcial Devices
  • Iso 9001
  • Qms Auditing
  • Medical Devices
  • Capa
  • Iso 9000
  • Quality Control
  • New Product Development Guidance
  • Iso 13485
  • Usability Engineering
  • Product Development
  • Corrective and Preventive Action (Capa)
  • Ce Marking for Medical Devices
  • Iec 60601 Medical Devices Requlatory Compliances
  • Regulatory Requirements
  • Validation
  • Regulatory Affairs
  • Quality Auditing
  • Iso Standards
  • U.s. Food and Drug Administration (Fda)
  • Manufacturing
  • Testing
  • Quality System

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Athikesavan R — Medical Device Assessor at SGS in Chennai, TN, IN | Unifers