Profile Details

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USD 125 /hr

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Hire Dr. Hrishikesh G.

United States

USD 125 /hr

Over 30 years of experience commercializing medical devices for large, mid-size and early stage companies.

Profile Summary

Broad hands-on software and hardware development for medical devices such as diagnostic imaging devices (PET, MRI, X-Ray and Ultrasound), blood transfusion devices, hypodermic needles/syringes and implantable neurostimulators. Extensive experience testing medical devices to show compliance (such as, Sterilization, Packaging, Aging, Biocompatibility, Electrical Safety, EMI, etc.) with international ISO/AAMI standards. Prepared, submitted and secured 510(k), De Novo, PMA, HDE and EAU for medical device manufacturers.

Subject Matter Expertise

• ★ Product Development
• ☆ Signal Processing
• ☆ Matlab
• ☆ Preclinical Research
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Wearable Technology
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Medical Imaging/Radiology
• ☆ Regulatory Affairs
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Software Development
• ☆ Software QA & Testing
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ PreMarket Approval (PMA) Applications
• ☆ Clinical Trial Protocol Writing
• ☆ Risk Management

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing

Research Market Research, Feasibility Study, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Algorithm Design-Non ML, Data Visualization

Product Development Formulation

Work Experience

President/CEO

Idonea Solutions, Inc.

June 2009 - Present

Education

PhD in Electrical Engineering

University of Tennessee

January 1987 - May 1991

Certifications

• Certification details not provided.