Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 125 /hr

★★★★★

☆☆☆☆☆

Hire Mohan M.

India

USD 125 /hr

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

Profile Summary

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

Subject Matter Expertise

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

Services

• Writing
• Consulting

Writing Technical Writing

Consulting Scientific and Technical Consulting

Work Experience

Director

SRE-MEDDEV

January 2020 - Present

Director

SRE-MEDDEV

January 2020 - Present

Manager

Wipro GE Healthcare Pvt Ltd

September 2005 - December 2019

Manager

Wipro GE Healthcare Pvt Ltd

August 2000 - August 2005

Manager

Kirloskar Electric Company Limited

March 1988 - August 2000

Lecturer

BMS College of Engineering

June 1984 - June 1986

Education

M.E. (Control Systems)

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

July 1986 - February 1988

B.E. (Electronics Engineering)

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

July 1978 - April 1983

Certifications

• Certification details not provided.