プロフィール詳細

プロジェクトを作成

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ASHU A.に依頼

India

Quality and Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submission & ISO 13485 Lead Auditor

プロフィール概要

I have over 7 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable medical devices and CE Marking Certification (MDD 93/42/EEC and MDR 2017/745)& USFDA 510 (k) I have experience in routinely preparing a Clinical Evaluation Plan and Report (CER, according to MEDDEV 2.7/1-Rev.4), Biological Evaluation Plan and Report (BER, according to ISO 10993), Risk Management File (according to ISO 14971), Post-Market Surveillance Plan and Report (PMS), Post-Market Clinical Follow-up Plan and Report (PMCF, according to MEDDEV 2.12-2); Writing Stability Study Plan and Stability Study Report for Implantable Medical Device and Instruction for the Use of implantable Medical Devices classes IIb and III, according to Medical Device Regulations MDD 93/42/EEC and MDR 2017/745. I have the experience to register Medical device in US, European Countries and ASIAN Countries. I hold a Master's degree in Bio-Medical Engineering , from the DCRUST, State University In India.

専門分野

• ★ Product Compliance
• ★ Clinical Study Reports

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Prototyping

職務経験

Manager - Regulatory and Quality Affairs

SIORA SURGICALS PVT. LTD.

2017 - 現在

Manager Regulatory Affairs

AUXEIN MEDICAL

10月 2013 - 12月 2016

学歴

MASTER IN BIO-MEDICAL ENGINEERING

Deenbandhu Chhotu Ram University Of Science And Technology

7月 2011 - 7月 2013

認定資格

• 認定資格の詳細は未入力です。