Prashant Kumar Email & Phone Number

Ahmedabad, Gj, In

Ahmedabad, Gujarat, India

Delhi, India

● Preparation and review of Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP) for medical devices as per Meddev 2.7/Rev4, MDR 2017/745.● Preparation and updates of PMS plan, PMS Report, PMCF plan, and PMCF report.● Developed the Standard operating procedure (SOP) for the claim matrix development process for the client as per EUMDR.● Preparation of the claim matrix through technical documentation and Marketing Materials.● Preparation of the Periodic safety update report (PSUR) template as per MDR and MDCG guidance.● Preparation of response to the NB query on CER and CEP.● Preparation and review of the Technical documentation for CE as per MDR.● Development rationale/justification for classification rule 21 as per the intended use/indications of medical device. ● Support in literature search and review including supportive data extraction.● Provide training and guidance to the Graduate engineer trainee to help with conducting literature searches on product/product families.● Critically appraise scientific literature and write clinical summaries for products.● Hand-on experience on complaints analysis in various vigilance databases like MAUDE, FDA Recall, TGA DAEN, and Recall, Health Canada.● Analyse the GSPR requirement for medical device products as per the GSPR checklist.● Preparation of SSCPs as per the MDR.● Good searching experience on PubMed, Medline, Embase, Google Scholar, Cochrane, and Science Direct databases.● Support in writing the State of the Art when developing the CER.

Sonipat, Haryana

• Working with Project Managers to discuss project function, processes, and productivity, while offering solutions to current issues.• Researched on the polymer biomaterials and developed the Knee and Shoulder arthroscopy medical implants.• Researched on the coating materials such as antibiotic coatingand Hydroxyapatite coating on medical devices.• Worked on the project of development the total hip replacement and developed the hip prosthesis.• Currently working on the Passivization of stainless steel surgical instruments.• Working in a Post Market clinical follow-up study or surveillance (PMCF & PMS) studies.• Faced CE surveillance audit.• Leading the project of Biocompatibility of materials (PEEK, Titanium, UHMWPE & Stainless steel) through ISO standards.• Development of the study documents such as Case report form, Study protocol, PMCF & PMS report and Clinical Evaluation Report (CER).• Writing research article and project for publication and funding.• Wrote daily reports and organized data presentations for accountability and quality assurance.

Master'S Degree, Industrial And Product Design

Bachelor Of Technology - Btech, Mechanical Engineering

Intermediate, Science