Neeraj Ahlawat

Rich understanding of Product Safety, Compliance, Regulations and Testing; procuring CE certificate for the sales of the product & enabling organization in selling Medical Devices across globe Responsible for CE marking of products as per Regulation EU-MDR 2017/745 guidelines. Prepare & Review of EU Technical Documentation, Clinical performance Report (CPR). Clinical Evaluation Report (CER), General Safety and performance Requirement (GSPR). Ensuring the compliance to Medical Device Rules (MDR) 2017 as per governed by Central drug Standard Control Organization (CDSCO) for Medical Device, India. Preparation and Technical Evaluation of Dossier and files for WHO, ISO, CDSCO, State FDA. Ensuring the compliance and preparation of regulatory documents for test license application, Import License and loan license, Medical device file as per Medical Device rules (MDR) 2017 and keep updating them as per latest Regulatory Requirements. Creating Summary of safety and performance and summary of safety and clinical performance for high risk class devices to enhance transparency and provide adequate public access to summarize data on safety and performance to intended users. Rich Understanding of Risk Management as per ISO 14971 Rich Understanding of all Validation of Process & Equipment’s Deep Understanding of Supplier Selection, evaluation & Supplier Rating Deep process knowledge of ETO Sterilization & Gamma Sterilization

Date of Birth: 06/25/1980

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