Profile Details

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Hire Beliz A.

Turkey

USD 100 /hr

Freelance Medical Writer, Medical Device Expert, 9+ years of Experience in Medical Device Industry

Profile Summary

Bioengineer passionate about medical devices but even more loves to build meaningful, evidence-based relationships between medical devices and human biology.. 9+ years of experience within the medical device quality systems arena. I have been involved in all phases of medical device design and production, CE, and ISO 13485 certificates preparation. Therefore, when preparing a clinical evaluation report, I have a broad vision of the risks and clinical evaluation framework. I bring over 9 years of expertise in Clinical Data Evaluation Reports (CER) for a diverse range of medical devices, from Class I to Class III, including those with and without drug components as a Medical Writer. My background as a Medical Writer in healthcare industry is further strengthened by my academic training during my Bachelor's degree, where I gained in-depth knowledge in areas such as Biomaterials, Biomechanics, Cardiovascular Fluid Mechanics, Cell Biology, and Human Anatomy. This educational foundation enables me to approach my work with precision and attention to detail, ensuring the highest quality in the reports I prepare. I have a project that I prepared with the support of TÜBİTAK, a respected state-affiliated institution of Turkey. "Numerical Calculations and Experimental Measurements of Flow Profiles and Wall Shear Stresses on Vessel Models Which are Clogged at Different Ratios". I also have experience with cosmetics, biocidal and OTC products. For more details about my experiences please visit my LinkedIn account: https://www.linkedin.com/in/belizkarcilaraydin-medicaldevice/

Subject Matter Expertise

• ★ Medical Device Literature Reviews
• ★ Medical Writing
• ★ Risk Management
• ☆ Medical Device Development
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485

Services

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

Writing Technical Writing, Copywriting, Newswriting

Research User Research, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Product Validation, Concept Development, Prototyping

Work Experience

Consultant

Medical Device Expert

June 2021 - April 2022

Senior Quality Assurance Specialist

Turkuaz Healthcare

July 2017 - June 2021

Quality Assurance Specialist

Zimmer Biomet

July 2016 - June 2017

R&D Engineer

Bıçakcılar Medical Devices

March 2016 - June 2016

Quaity Assurance Assistant Specialist

Bıçakcılar Medical Devices

January 2015 - January 2016

Education

M.S Neuroscience

Istanbul University

September 2014 - September 2015

Genetics and Bioengineering (English)

Fatih Univesity

September 2009 - September 2013

BSc. Biology

Trakya University

September 2007 - September 2009

Certifications

• Pre-Clinical/Biocompatiblity Training in Medical Devices and Biocompatibility Workshop

  EUmed Consuting

  November 2021 - Present

• Calibration-Measurement Management Systems - Requirements for Measurement Process and Measuring Equipment

  Markcert Global Conformity and Compliance

  November 2020 - Present

• ISO 11462-1:2001 ISO 11462:2010 Guidelines for Implementation od Statisical Process Control (SPC)

  Markcert Globat Conformity and Compliance

  October 2020 - Present

• ISO 17665-1:2006 Sterilization of Healthcare Products - Moist Heat

  Markcert Global Conformity and Compliance

  October 2020 - Present

• Basics of Good Clinical Practices

  T.C Ministry of Health of Turkey

  August 2020 - Present

• ISO 13485:2016 QMS Lead Auditor Training

  bsi

  April 2020 - Present

• R&D Focussed Patent Training

  Inter Patent

  December 2019 - Present

• EN ISO 13586:2016 QMS Transition and Process Validation Training

  ERA Management

  July 2019 - Present

• ISO 14971:2012 Medical Device Risk Management Training

  ERA Management

  May 2019 - Present

• Medical CE - Medical Devices Regulation (Medical Devices Regulation EU 2017/745)

  Kiwa

  November 2017 - Present

• Environmental Management System ISO 14001:2004 to ISO 14001:2015 Transition Training

  bsi

  September 2015 - Present

• Certified Internal Auditor

  Bureau Veritas

  September 2015 - Present