Profile Details

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USD 60 /hr

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Hire ALOKEPARNA C.

India

USD 60 /hr

Medical Device Regulatory Affairs Consultant | QMS, DHF, EU MDR, ISO 13485

Profile Summary

I help medical device startups, diagnostic innovators, and digital health companies build robust and compliant documentation aligned with ISO 13485, EU MDR, and FDA QSR standards. I’ve worked on QMS setup, DHF file creation, risk management (ISO 14971), and internal audit readiness for global clients. Services include: Gap assessments and QMS documentation SaMD-aligned design documentation (xxxxxxxxxxx) Technical file compilation and GSPR mapping Supplier audit readiness and CAPA management Let’s ensure your quality system is audit-ready and globally compliant.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ 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
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Lab-on-a-Chip Devices
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Healthcare Administration & Management
• ☆ Medical Affairs
• ☆ Healthcare Quality Improvement
• ☆ Medical Equipment & Supplies
• ☆ Product Evaluation
• ☆ Supply Chain & Logistics
• ☆ Inventory Control
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Survey Design & Methodology
• ☆ Meta-Research
• ☆ Feasibility Studies
• ☆ Technology Scouting
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Gray Literature Search
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Course Content Writing
• ☆ Risk Management

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, General Proofreading & Editing

Research Gap Analysis

Consulting Healthcare Consulting

Product Development Manufacturing, Quality Assurance & Control (QA/QC)

Work Experience

Lead, QARA

Awak Technologies Pvt. Ltd.

November 2024 - Present

Team Lead, Quality and Regulatory

Oivi Tech Pvt. Ltd.

April 2019 - November 2024

Education

Healthcare Management

Indian Institute of Management, Calcutta

March 2019 - April 2020

MSc Biotechnology

VELLORE INSTITUTE OF TECHNOLOGY, VELLORE

January 2012 - January 2014

Certifications

• CQI and IRCA Certified Medical Devices - Quality Management Systems Auditor/Lead Auditor Training Course (ISO xxxxxxxxxx)

  bsi

  January 2025 - Present