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Profile Details
Create Project
USD 100 /hr
Hire Sundeep A.
USD 100 /hr

Medical Device, IVD, QMS, CE Certificate, FDA 510(K), EU MDR, MDSAP, ISO 13485, SaMD, PMS, CER , PMCF, Risk Management

Profile Summary
Subject Matter Expertise
Writing Clinical Trial Documentation, Technical Writing, Copywriting
Research Systematic Literature Review
Consulting Scientific and Technical Consulting
Work Experience

Regulatory and Quality Affairs - SME

Freelancer Consultant

May 2021 - Present

General Manager


April 2013 - April 2021

Manager & Lead Auditor

SCS Global

November 2010 - March 2013


Master of Technology - Quality Management

Birla Institute of Technology and Science, Pilani, India

June 2015 - June 2017

Advance Quality Management

Indian Institute of Management, Ahmedabad, INDIA

June 2015 - June 2015

Post Grad. Dip. - Medical law & Ethics

National Law School of India University

June 2013 - June 2014

  • GCP Certified


    November 2018 - Present

  • Lead Auditor ISO 13485, 9001, MDSAP, USFDA 21 CFR part 820

    SGS, BSI, UL

    November 2010 - Present

  • Regulatory Affairs and Quality Assurance

    Duke University School of Medicine

    April 2017 - July 2017