Sakshi Gurbani
Senior Engineer @Tata Elxsi
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WORK HISTORY
Senior Engineer @Tata Elxsi
Pune, IN
Create Biocompatibility Evaluations, determine rationales and test strategies to address the appropriate endpoints to ensure safety and comply with the relevant regulatory standards.• Experience in biocompatibility pre-assessment and drafting Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) as per EUMDR requirements• Supported in chemical characterization for extractable and leachable testing for Medical devices: Actively participate and contribute in safety assessment related issues and Supporting for testing protocol of biocompatibility studies and extractable and leachable for medical devices in accordance with ISO 10993-1; 12; 17; and 18; FDA guidelines.• Scientific literature searches, extracting toxicity data as well as calculating Analytical evaluation threshold (AET).• Manage appropriate Safety, Exposure, and/or Risk assessments on ingredients/ Raw materials and final finished products.• Provide justification according to the device regulations related to materials (eg: BPA, chemicals of concerns (COC), SVHCs) and impact on final finished device. Interact with suppliers to obtain necessary compliance data and conduct assessments and document the information in technical reports.
EDUCATION
Nirma University, Ahmedabad, Gujarat, India
Master of Pharmacy
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor's degree
ABOUT SAKSHI GURBANI
Detailed and research-oriented engineer with experience in biocompatibility evaluations per industry standards such as ISO 10993, performing gap assessments, and EU MDR remediation. Strong proficiency in technical and scientific writing, providing technical justifications according to regulatory compliance, and excellent communication skills. Background in materials science research in highly regulated industries (medical device- application to biological safety assessment)
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