プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Kavita S.に依頼

India

Experienced Medical Device Regulatory Affairs professional

プロフィール概要

We are a team of experienced regulatory compliance expertise for Medical Devices and In-Vitro diagnostic devices across all risk classes. We have prior experience in writing CERs for Medical Devices with specialties in cardiovascular, spine, orthopedics, and general surgery. Our website: https://dceservices.in/

専門分野

• ★ European Medical Device Regulation (MDR)
• ★ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ★ Clinical Evaluation Reports (CER)
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Medicine
• ☆ Medical Sciences
• ☆ Product Compliance
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Feasibility Study, Systematic Literature Review

Consulting Scientific and Technical Consulting

職務経験

Sr. Executive Marketing & Human Resources

DCE Services

8月 2019 - 現在

学歴

Post Graduate Diploma in Management (PGDM)

Institute of Management Technology, Ghaziabad

9月 2016 - 5月 2018

M.Tech Biomedical

Vellore Institute of Technology

9月 2013 - 5月 2015

認定資格

• 認定資格の詳細は未入力です。