Avinash Kishor Email & Phone Number

Noida, Uttar Pradesh, India

Noida, Uttar Pradesh, India

• Good know-how of medical device standard such as ISO 13485, ISO 14971, ISO 24971, ISO 10993 and regulations EU MDR.• Experience on Creating and updating 80+ CERs per the MEDDEV 2.7/1 REV 4, MDD, MDR and ARGMD guidelines for Class I, IIa, IIb, III and custom-made medical devices.• Created and updated various Quality management Systems (SOP, Work Instruction, DCO and Quality Manual) for US based medical device companies.• Developing and remediating technical files as per the EU MDR and MDD guidelines across therapeutic areas such as orthopedic implants and instruments, spinal and epidural pain management system and patient monitoring systems.• Created PMS procedures, plans and reports for the Class I, IIa, IIb, III medical Implants per EU MDR.• Having good experience in Creating Biological Evaluation Plan and Report per ISO 10993.• Hands on experience on complaints analysis in various vigilance database like MAUDE, FDA Recall, TGA DAEN and TGA recall, Health Canada, MHRA and BfArM.• Analyze the GSPR requirement for various medical device product as per the GSPR checklist.• Conducted audits of QMSes for ISO 13485 compliance for a large US based company.• Created and developed the PMCF and PSUR procedures, plans and reports for both low and high-risk classes medical devices.• Experience on the risk assessment, Risk management plan, Risk management report and device hazard Analysis per ISO 14971.• Provided training on the Quality management system and various quality procedures.

Noida, Uttar Pradesh, India

Noida, Uttar Pradesh, India

Preparation of clinical evaluation reports of medical devices and preparation of template and SOP of CER according to MEDDEV 2.7.1 Revision 4 guidelines.

Ghāziābād Area, India

• Good working experience of part modeling, Assembly, and detail drawing on creo 4.0.• Comprehensive exposure in end-to-end development of engineering products from requirement analysis to Prototype development using tools like cero 4.0 and solid works. • Develop new concept Conceptualization, Design and Development of different medical parts.• Experience in creating and updating Technical document like SOP and DCO.• Create and updating existing drawings with note, Surface finish symbol as well as GD&T using Cero 4.0 solid works according to client requirement.• Worked on Bench marking/VAVE of a system to with equivalent device.• Create Op-tech (Surgical technique) weekly report and MOM of meeting with client.• Tolerance stack up analysis of complete assembly