
Fatemeh Rousta
Training Manager, Medical Device Maintenance Specialist

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About me
Active Medical Device Auditor
Education

Shahid Beheshti University of Medical Sciences
-Master of Science - MS Biomedical/Medical Engineering
Amirkabir University of Technology - Tehran Polytechnic
-Bachelor's degree Biomedical/Medical Engineering
Shahid Beheshti University of Medical Sciences
-Doctor of Philosophy - PhD Biomedical/Medical Engineering
Experience

Amadgah 501
Nov 2007 - Jun 2017Training Manager, Medical Device Maintenance Specialist
Islamic Azad University
Oct 2011 - Oct 2015Visiting Professor
Khatam University of Applied Science and Technology (UAST)
Oct 2012 - Jul 2024Visiting Professor
Lotus Teb Parsian
Sept 2017 - Jul 2024R&D and RA Manager
Fartakmedical
Oct 2020 - Mar 2022Product Development and Regulatory Specialist
IVistaMed
Dec 2020 - Aug 2022Regulatory Affairs Manager
Soroush Salamat Sina
Oct 2021 - Jul 2024Healthcare Equipment Acquisition and Integration Specialist
International Global Certification
Nov 2022 - Jul 2024Medical Device Auditor
Clinical Technology Innovation Centre
Jul 2023 - Jul 2024Executive Project Manager
TÜV SÜD
Jul 2024 - nowActive Medical Device Auditor
Licenses & Certifications

Requirements for obtaining IEC60601-1 and IEC60601-1-2
Iranian Govah Kosar
Risk Management based on ISO 14971
Iranian Govah kosar
Technical supervisor for manufacturers of medical equipment retraining course
Iranian medical Device DirectorateMar 2019
Medical Device Quality Management System- ISO13485.
Rabin Sanjesh IranianAug 2018
Quality control of biomedical equipment primary course
OSSJun 2016
Quality control of x-ray, fluoroscopy, dental radiography equipment
Parsian Radiation Dosimetery ServiceAug 2011
Radiation protection for medical centers
Ashna Partou SayanJul 2011
Technical supervisor for manufacturers of medical equipment
Iranian medical Device DirectorateJul 2010
Understanding how medical device are regulated in Canada
Health Canada | Santé Canada
ISO13485:2016 Lead Auditor Training Course
Exemplar Global, Inc.Aug 2022
Volunteer Experience
Head of Production Committee
Issued by Iranian Medical Device Society (IMEDSS) on Jun 2022
Associated with Fatemeh RoustaMember of the Central Council
Issued by Research Institute of Gastroenterology and Liver Diseases Innovation Center on Jun 2023
Associated with Fatemeh RoustaSecretary of Scientific Comitee
Issued by Iranian Medical Device Society (IMEDSS) on Sept 2015
Associated with Fatemeh RoustaScientific Secretory
Issued by Development of Modern Medical Technologies Magazine on May 2020
Associated with Fatemeh Rousta
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