プロフィール詳細

プロジェクトを作成

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Ojas K.に依頼

India

End-to-end IVD consultant specializing in ISO 13485, CE-IVDR compliance, QMS, and diagnostic product development

プロフィール概要

IVD regulatory and product development specialist with 10+ years of experience in diagnostic virology, immunoassay development (ELISA, rapid tests), and global regulatory compliance (ISO 13485, CE-IVDR, CDSCO). Proven track record in developing and commercializing diagnostic kits, leading successful regulatory audits, and building compliant QMS systems from scratch. Experienced in supporting IVD and medical device companies with technical documentation, audit readiness, and end-to-end product development—from concept to market.

専門分野

• ☆ Microbiology
• ☆ Virology
• ☆ Coronaviruses
• ☆ Zika Virus
• ☆ Retrovirology
• ☆ Cytomegaloviruses
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Basic Immunology
• ☆ Adjuvant & Antigen Research
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ 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
• ☆ Clinical Immunology
• ☆ Health Technology Assessment
• ☆ Medical Equipment & Supplies
• ☆ Regulatory Writing
• ☆ Medical Writing
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ Spec Sheets
• ☆ Textbook Content Writing
• ☆ Science Communication

サービス

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

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, General Proofreading & Editing

Research Gap Analysis, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Financial Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Data Processing, Data Insights

Product Development Formulation, Recipe Development, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Packaging Design, Prototyping, Reverse Engineering

職務経験

Director

Advise MD

9月 2024 - 現在

Director

Advise MD

9月 2024 - 現在

Operations and R&D head

Paramcare Lifesciences Private Limited

5月 2022 - 9月 2024

Operations and R&D Head

Paramcare Lifesciences Private Limited

5月 2022 - 9月 2024

Researcher

ICMR National Institute of Virology

1月 2014 - 4月 2022

Co-owner

Sequencia

7月 2012 - 12月 2013

学歴

M.Sc. Microbiology

University of Pune

7月 2010 - 5月 2012

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

Ojas Kaduskar, Gururaj Rao Deshpande, Ketki Deshpande, Vaishali Bhatt, Pragya Yadav, Yogesh Gurav, Varsha Potdar, Kirti Khutwad, Shankar Vidhate, Asha Salunke, et al.(2021). Longitudinal clinico-serological analysis of anti-nucleocapsid and anti-receptor binding domain of spike protein antibodies against SARS-CoV-2 . International Journal of Infectious Diseases. 112. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 103--110. Elsevier {BV}