プロフィール詳細

プロジェクトを作成

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Dr. Grace C.に依頼

Malaysia

Experienced CER Writer for medical device companies

プロフィール概要

1. Clinical Evaluation Report (CER) writer and authoring of Clinical Evaluation Plan (CEP) in accordance with Medical Device Regulation (MDR), 93/42/EEC Medical Device Directive (MDD) and MEDDEV 2.7/1 Rev. 4 for companies such as Bausch and ConvaTec. 2. CEP and CER Technical Reviewer for Johnson and Johnson. 3. Writing PMCF Plans. 4. Performance Evaluation Report (PER) which include authoring of the Performance Evaluation Plan (PEP), Scientific Validity Report (SVR), Analytical Performance Report (APR) and Clinical Performance Report (CPR) in accordance with the In Vitro Diagnostic Device Regulation (IVDR) for companies such as Leica Biosystems Newcastle, Leica Amsterdam and Merck US. 5. Conducting systematic literature searches through databases including EMBASE, Cochrane Library and PubMed.

専門分野

• ★ Medical Devices
• ★ European Medical Device Regulation (MDR)
• ★ Clinical Evaluation Reports (CER)
• ☆ Medical Device Regulatory Consulting
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

職務経験

CER Writer

RQM

2月 2020 - 現在

Medical Writer

Oro Clean Chemie Sdn Bhd

7月 2017 - 11月 2019

Scientific Officer

Dyamed Biotech Sdn Bhd

4月 2016 - 4月 2017

学歴

Doctor of Philosophy (PhD) in Molecular Medicine

University of Malaya

2月 2011 - 4月 2016

Bachelor of Science (Hons) in Biotechnology

UCSI University

5月 2006 - 7月 2009

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

(2015). Antioxidant, antiproliferative, genotoxic and cytoprotective effects of the methanolic extract ofPadina tetrastromaticaon human breast adenocarcinoma and embryonic fibroblast cell lines . Frontiers in Life Science.

In vitro Antimicrobial Activity of Hexane: Petroleum Ether Extracts from Fruits of Momordica charantia L .

Antioxidant and cytotoxic activities of three species of tropical seaweeds .

Effectiveness of Maceration Periods with Different Extraction Solvents on in-vitro Antimicrobial Activity from Fruit of Momordica charantia L .