プロフィール詳細

プロジェクトを作成

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Mohan M.に依頼

India

Expert Freelance Consultant Standards, Regulatory Affairs & QMS for Medical Device Design & Manufacture

プロフィール概要

Over 35 years of broad experience as Engineering professional…Medical Device Product Regulatory Requirements, Product Design, Project Management, Quality Management Systems, Device Risk Management, Standards & Regulations for Medical Devices and Technical Teaching. Medical Device Certifications and Registrations…Device Labeling, Regulatory Submissions, Product Safety Reports per regulatory requirements. Medical Device Markings/Certifications/Approvals…CE, ISI, AERB, FDA 510k, China NMPA, Brazil ANVISA/INMETRO, Safety Marks from various NRTLs, Various Country Approvals/Registrations, Language Requirements. Certified Lead Auditor ISO 13485 & ISO 9001

専門分野

• ★ Medical Device Regulatory Consulting
• ★ European Medical Device Regulation (MDR)
• ★ Quality Assurance & Quality Control (QA/QC)
• ☆ Safety & Reliability Engineering
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Design
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Regulatory Affairs
• ☆ Product Compliance
• ☆ Risk Management

サービス

• Writing
• Consulting

Writing Technical Writing

Consulting Scientific and Technical Consulting, Regulatory Consulting

職務経験

Director

SRE-MEDDEV

1月 2020 - 現在

Director

SRE-MEDDEV

1月 2020 - 現在

Manager

Wipro GE Healthcare Pvt Ltd

9月 2005 - 12月 2019

Manager

Wipro GE Healthcare Pvt Ltd

8月 2000 - 8月 2005

Manager

Kirloskar Electric Company Limited

3月 1988 - 8月 2000

Lecturer

BMS College of Engineering

6月 1984 - 6月 1986

学歴

M.E. (Control Systems)

Bharathiar University: PSG Collage of Technology: Coimbatore, Tamil Nadu, IN

7月 1986 - 2月 1988

B.E. (Electronics Engineering)

Bangalore University: BMS Collage of Engineering: Bangalore, Karnataka, IN

7月 1978 - 4月 1983

認定資格

• 認定資格の詳細は未入力です。