プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

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☆☆☆☆☆

Sundeep A.に依頼

India

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

プロフィール概要

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, Quality Management System, GMP, Technical Documentation, Risk Management, Product Registration, Product Design & Development (PLCM), Commercial Scale-up, Industrial Manufacturing, Software Validation and Clinical Studies of medical devices. GLOBAL EXPERTISE: Global exposure includes India, Europe, United States, United Kingdom, Germany, South Korea, Malaysia, Indonesia, Sri Lanka. Bangladesh, Ghana, and South Africa. EXPERTISE: GMP, QMS - ISO 13485:2016, ISO 14971, CE marking, MDD, MDR, CER, GSPR, 510(k), 21 CFR Part 820, DHF, DMR, IEC 60601, IEC 62304, ISO 11135-1: 2007 & ISO 11137-2: 2013- Sterilization, ISO 10993 Bio-compatibility, Drug-Device Combination, Good Documentation Practice, and Good Clinical Practice.

専門分野

• ★ Medical Device Regulatory Consulting
• ★ European Medical Device Regulation (MDR)
• ★ ISO 13485
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ ISO 14971
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Technical & Scientific Writing

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Systematic Literature Review

Consulting Scientific and Technical Consulting

職務経験

Regulatory and Quality Affairs - SME

Freelancer Consultant

5月 2021 - 現在

General Manager

DMPL

4月 2013 - 4月 2021

Manager & Lead Auditor

SCS Global

11月 2010 - 3月 2013

学歴

Master of Technology - Quality Management

Birla Institute of Technology and Science, Pilani, India

6月 2015 - 6月 2017

Advance Quality Management

Indian Institute of Management, Ahmedabad, INDIA

6月 2015 - 6月 2015

Post Grad. Dip. - Medical law & Ethics

National Law School of India University

6月 2013 - 6月 2014

認定資格

• GCP Certified

  NIDA-CTA

  11月 2018 - 現在

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

  SGS, BSI, UL

  11月 2010 - 現在

• Regulatory Affairs and Quality Assurance

  Duke University School of Medicine

  4月 2017 - 7月 2017