プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Rakesh S.に依頼

India

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

プロフィール概要

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.

専門分野

• ★ Medical Devices

サービス

• 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

職務経験

Manager

Straits Orthopaedics

2月 2008 - 10月 2021

学歴

Masters of Science

Bharatiar university

7月 2006 - 7月 2008

認定資格

• ISO 13485 Internal Auditor for Medical Device

  bsi

  6月 2020 - 現在

• ISO 14971-Appilcation of Risk Management Medical device

  bsi

  12月 2019 - 現在

• FDA -21 CFR 820 Training on Medical device requirements

  TUV

  11月 2018 - 現在

• GHTF -Guidance on Medical device process Validation

  TUV

  5月 2018 - 現在

• Gamma Irradiation sterilization as per ISO 11137

  Steris

  4月 2017 - 現在

• ETO Sterilization as per ISO 11135

  Steris

  4月 2017 - 現在

• Lean Six Sigma

  SQMS

  2月 2017 - 現在