Mohammad Shafi
Senior Analyst at Hcltech
Based in Bengaluru, India
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Seniority
Staff
Department
Information Technology
Location
Bengaluru
Industry
IT Services and IT Consulting
Company size
254K
Contact information
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m•••••••@••••••.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Mohammad Shafi
Technical Documentation and GSPR creation and Remediation for the Class 2 & Class 3 medical devices such as Neurovascular implants, Guiding Catheters and other accessories. Execution of Product Labeling and Instructions for Use Requirements for MDR 2017/745 compliance. Review of Post-market surveillance data for Guiding catheters, Neurovascular Implants and accessories and implementation of review observations in the risk management documentation such as DFMEA, AFMEA, RMR, RMP, RTM etc. Creating the Benefit-Risk Analysis documents to justify the risks within the medical device. Creating the material mapping and defining the type of contact for the restricted substances Evaluation and Biocompatibility Workstream Updates. To develop / create a biocompatibility plan which shall be compliant to EU MDR & ISO 10993:2018 or whichever is the latest revision.
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