プロフィール詳細

プロジェクトを作成

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ALOKEPARNA C.に依頼

India

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

プロフィール概要

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.

専門分野

• ☆ 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

サービス

• 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)

職務経験

Lead, QARA

Awak Technologies Pvt. Ltd.

11月 2024 - 現在

Team Lead, Quality and Regulatory

Oivi Tech Pvt. Ltd.

4月 2019 - 11月 2024

学歴

Healthcare Management

Indian Institute of Management, Calcutta

3月 2019 - 4月 2020

MSc Biotechnology

VELLORE INSTITUTE OF TECHNOLOGY, VELLORE

1月 2012 - 1月 2014

認定資格

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

  bsi

  1月 2025 - 現在