Iqra Shehzad
Testing and Validation Lab. Coordinator at Medical Devices (Pvt) Ltd- Claim this Profile
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Bio
Credentials
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Forward Learner Program
McKinsey & CompanyJun, 2023- Oct, 2024 -
Training session on understanding the requirements of ETO sterilization ISO 11135 and Cleanroom Manufacturing ISO 14644 on Medical Devices by SGS
SGSSep, 2022- Oct, 2024 -
Introduction to the Biology of Cancer
CourseraJan, 2020- Oct, 2024
Experience
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Medical Devices (Pvt) Ltd
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Pakistan
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Medical Equipment Manufacturing
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1 - 100 Employee
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Testing and Validation Lab. Coordinator
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Jul 2019 - Present
• Clinical evaluation and PMCF of medical devices as per REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 • Scientific literature review for clinical benefits and usability of medical devices • EO sterilization validation of single-use medical devices as per ISO- 11135:201 • Validation, evaluation & testing of cleanroom as per ISO-14644-1 and associated monitoring to ensure continued compliance with the standard • Basic knowledge of HVAC system for cleanroom • Biocompatibility of medical devices as per ISO-10993-5 and ISO 10993-10 (In Vitro Cytotoxicity, Oral Mucosa, Irritation, and Skin Sensitization • Biological evaluation of medical devices as per ISO-10993-1 • Strong knowledge of ISO 11737-1 for bioburden monitoring with reference to product as well as clean room environment • Strong knowledge of USP <85>, 117373-2:2019, ISO 10993-7:2008/Amd.1:2019 for analysis of test performed after EO sterilization • Testing and validation of laryngoscopes as per ISO-7376:2020 • Development of SOPs required for testing of medical devices • Setting up protocols for validation and testing of medical devices • Technical report writing summarizing the results of testing and validations conducted on medical devices • Investigation report writing of clients complain and diagnosis of identified problem after performing required testing • Filling of CAPA and SCAR form for internal and external non-conformances • Collaboration with quality assurance department to assist them in record keeping and documentation required by QMS • Possess basic understanding of QMS based on ISO 9001:2019 and ISO 13485:2016. • Collaboration with regulatory affairs department for regulatory compliance management • Collaboration with sales and marketing department for development of post market surveys and questionnaires/clinical investigations • Record keeping of all the technical documentation Show less
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National University of Sciences and Technology (NUST)
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Pakistan
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Higher Education
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700 & Above Employee
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Scientific Researcher
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Jul 2018 - Sep 2019
• Development Balb/c mice models of Leukemia • Testing of Crithmum maritimum extract on leukemic model of Balb/C mice • Experience in animal handling, H&E staining for histopathology slides, and flow cytometry FACS for investigating apoptotic activity • Strong knowledge of Mendeley for referencing the literature review • Strong knowledge of SPSS and Minitab for statistical analysis • Development Balb/c mice models of Leukemia • Testing of Crithmum maritimum extract on leukemic model of Balb/C mice • Experience in animal handling, H&E staining for histopathology slides, and flow cytometry FACS for investigating apoptotic activity • Strong knowledge of Mendeley for referencing the literature review • Strong knowledge of SPSS and Minitab for statistical analysis
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Education
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2017 - 2019
National University of Sciences and Technology (NUST)
Master of Science - MS, Biomedical Sciences -
2012 - 2016
University of Gujrat
Bachelor of Science - BS, Botany/Plant Biology
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