Prasad N Email and Phone Number

✓ Worked as a system engineer, and experience in functionality testing, System integration testing and writing test protocols.1) Identifying and fixing the mechanical hardware issue in medical devices such as pneumatic Valve issues, circulation issue, solenoid valve issues.2) Worked for PMS Medical device complaints handling, experience on 21 CFR 803, ISO13485, ISO 14971, 21 CFR 198.3) AER assessment and identify reportability of the complainant and creating MDR and making… Show more ✓ Worked as a system engineer, and experience in functionality testing, System integration testing and writing test protocols.1) Identifying and fixing the mechanical hardware issue in medical devices such as pneumatic Valve issues, circulation issue, solenoid valve issues.2) Worked for PMS Medical device complaints handling, experience on 21 CFR 803, ISO13485, ISO 14971, 21 CFR 198.3) AER assessment and identify reportability of the complainant and creating MDR and making submission.4) Hands on information gathering on death and serious injuries during the complainant intake. hands on Working with MedWatch forms.5) Hands on assigning the IMDRF codes to the reported complaints.6) Performing the preliminary investigation of complaint based on the complainants received.7) Reviewing and approving the inspection plans for manufactured medical components.8) Preparing reports of manufacturer on Key performance indicators (KPIs).9) Verifying the inspection documents against the PQP (product quality plan)10) Identifying the Non-conference of manufactured parts and checking for immediate action. Show less