Profile Details

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Hire Rakesh S.

India

USD 50 /hr

Exp in Medical Device Packaging,Clean room Operations,Sterilizationand Medical device process Validation

Profile Summary

Specialized Focus Areas: • Standards and Regulations of Medical Device ISO 13485 and 21 CFR part 82 • Sealing process characterization study based on ISO 11607 • Medical device Sterilization as per ISO 11135, ISO11137 & ISO 17665 • Validations as per GHTF requirements • Cleanroom Operations as per ISO 14644 • Biocompatibility data collection as per ISO 10993 • Cleaning and Special process for Medical Device as per ASTM Standards • Medical Device packaging project transfer In a career spanning 12+ years to date of professional experience in the field of Medical Devices; I have had the opportunity to engage in Packaging Project transfer and Validations of well renowned OEM of USA,UK, Australia and Singapore.

Subject Matter Expertise

• ★ Medical Devices

Services

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing

Research Market Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Concept Development

Work Experience

Manager

Straits Orthopaedics

February 2008 - October 2021

Education

Masters of Science

Bharatiar university

July 2006 - July 2008

Certifications

• ISO 13485 Internal Auditor for Medical Device

  bsi

  June 2020 - Present

• ISO 14971-Appilcation of Risk Management Medical device

  bsi

  December 2019 - Present

• FDA -21 CFR 820 Training on Medical device requirements

  TUV

  November 2018 - Present

• GHTF -Guidance on Medical device process Validation

  TUV

  May 2018 - Present

• Gamma Irradiation sterilization as per ISO 11137

  Steris

  April 2017 - Present

• ETO Sterilization as per ISO 11135

  Steris

  April 2017 - Present

• Lean Six Sigma

  SQMS

  February 2017 - Present