Profile Details

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USD 100 /hr

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Hire Sachin M.

India

USD 100 /hr

Medical Device Executive/ Medical Writer/CER Writer

Profile Summary

I am a medical device executive for last 20 years and have developed two innovative products, one nanotechnology based product among that. I have taken technologies from basic R&D to final product development. I have taken the company through ISO certification process and 2 products through CE marking process. I have written several CERs, risk management reports, clinical protocols, etc. I have taken 5 products through the 510(K) approval process.

Subject Matter Expertise

• ★ Clinical Evaluation Reports (CER)
• ☆ Medical Device Regulatory Consulting
• ☆ Medical Device Regulatory Writing
• ☆ Medical Writing

Services

• Writing

Writing Clinical Trial Documentation, Technical Writing

Work Experience

Consultant

Panacea Medical Consultants

October 2016 - Present

CEO

Orthogen LLC

October 2002 - Present

Education

MS

Rutgers University

January 2000 - June 2002

MD

University of Pune

August 1992 - December 1997

Certifications

• Certification details not provided.