N Mohan Prasad
Jagathgirigutta
Summary
A highly motivated medical device professional with 13+ years of experience into the medical device industry and CRO. Have experience into Regulatory Affairs, devices demonstration and market research. Dedicated MedTech professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior Manager – MedTech Regulatory Affairs
Techsol Lifesciences Pvt Ltd
11.2022 - Current
- Facilitate accurate and timely approval of submissions by ensuring compliance with FDA and Health Canada regulations and interpretations
- Interact with regulatory agency personnel in order to expedite approval of applications, and responses to questions
- Partner with R&D, Marketing and other cross functional groups to compile appropriate technical information for supporting various regulatory submissions
- Develop and maintain technical files for compliance to EU Medical Device Directive (MDD), Medical Device Regulation, IVDD and IVDR, CDSCO
- Provide training and regulatory guidance, subject matter expertise to product development teams regarding specific product submission requirements
- Review proposed design and/or labeling changes to ensure regulatory compliance
- As needed, conduct training programs to educate employees on regulatory requirements, Standard Operating Procedures and Policies (SOPPs) and good regulatory practices
- Lead and participate in projects as assigned by management to improve regulatory processes and facilitate best practice approach to drive functional excellence
- Develop and track metrics for department performance.
Design Quality Engineer
Cyient ltd.
12.2020 - 11.2022
- Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements
- Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations
- Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support the market needs
- Participate with cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report)
- Review Design History Files and Technical Files for conformance to applicable requirements
- Participate when appropriate in internal and supplier audits
- Provide Quality support to facilitate resolution of product complaints and/or safety issues
- Provide support to the Regulatory Department in writing technical submissions
- Ensure corrective measures meet acceptable reliability standards and documentation is compliant with requirements of Quality Systems, Design Controls and Risk Management for Reliability to streamline processes
- Experience and knowledge of medical device standards with ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1/ 1-2 and IEC 62304
- Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report
- Assist with DFMEA creation for new product development
- Ensure a regular review of all active DFMEAs
- Ensure that product development projects are conducted in compliance with FDA Quality System Regulations
- Participates in compiling product performance for specific medical device groups or sub-groups
- Compilation and review of Hazardous Material Assessment, Biocompatibility Assessment and Customer needs
- Compilation of PSURs, PMSRs and SSCPs in accordance with EU MDR.
Team Lead-Global Regulatory Services
Freyr Solutions services private limited.
01.2019 - 12.2020
- Primarily focuses on preparing, writing (technical aspects) documents and responses to regulatory authorities (e.g
- Notified bodies)
- Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g
- MEDDEV 2.7.1, Medical Device Directives (MDD) & Medical Device Regulations (MDR), IVDR, IMDRF)
- Preparation and review of Non-Clinical Test Summaries
- Preparation and review of Design and Biological Parameters summaries
- Participates in post-market surveillance activities by conducting routine, systematic literature for specific medical device groups or sub-groups
- Developed clinical evaluation reports (CERs), Performance evaluation reports (PERs) for European commission and notified bodies in accordance with EU MDR 2017/745, MDD 93/42/EEC and IVDR 2017/746
- Reviewed and supported in establishing 15 Scientific Validity Reports and Clinical Performance Reports for IVD’s in accordance with IVDR 2017/746
- Preparing Technical File and related technical documentation for medical devices filing into EU and US FDA
- Documentation as per ISO 13485 and MDD 93/42/EEC
- Performing gap analysis and gap remediation for the medical devices as per new EU MDR
- Review and updating RAM’s document based on AE’s based on literature search
- Providing presales support to BD team
- Addressing non-conformities received from notified bodies and addressing the gap in the document
- Evaluate and update existing procedures (SOP), Work instructions, etc
- Assisting worldwide clients of Medical Device Industry
- Subject matter expert for the CER’s, PER’s, SVR’s and CPR’s.
Biomedical/Medical Device Engineer
Makrocare Clinical research ltd.
06.2017 - 12.2018
- Primarily focuses on preparing, writing (technical aspects) documents and responses to regulatory authorities (e.g., Notified bodies)
- Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g., MEDDEV 2.7.1)
- Participates in post-market surveillance activities by conducting routine, systematic literature for specific medical device groups or sub-groups
- Developed clinical evaluation reports (CERs) for European commission and notified bodies
- Reviewed and supported technically nearly 30 plus clinical evaluation reports (CERs) from end-to-end CER to verify the safety and performance of the medical devices
- Expertise in equivalence demonstration of medical devices as per MEDDEV guidelines
- Review of technical documents and performing gap analysis and/or gap remediation for technical files, reclassification, or up-classification of the medical devices as per new EU MDR Vs MDD
- Review of RAM’s document based on AE’s based on literature search
- Providing presales support to BD team
- Creation and updating SOPs for 510k and PMA.
Application Engineer
ESAOTE INDIA (NS) ltd.
12.2012 - 06.2017
- Dealt with all the product range of Esaote’s low- end to High – end machines, which includes all the applications like Radiology, Cardiology, Vascular and Gynecology
- Worked closely with leading Cardiologist and Radiologist
- Worked with Tender team on various Government tenders
- Preparing technical specifications, attending Pre-Bid technical meetings and commercial meetings
- Attended various national level and State level conferences and workshops for promoting Organization’s presence South & Central India
- Handling all the customers for presale & post sale application support
- Personally handled Customer queries to ensure promotional activity and to solve their query on machines.
Service Engineer
TEES Medical Systems
06.2011 - 11.2012
- Was part of service team and used to look after service issue in and around Hyderabad and entire Andhra Pradesh region
- Cardiology: dealt with ECG machine & Patient Monitors service & application support after sale
- Anesthesia & Diathermy: dealt with service & application support for Diathermy unit, Work Station & Anesthesia machines
- Critical Care: dealt with Ventilators, Syringe pump, Infusion pump, Patient Monitors.
Education
B. Tech (BME) -
J.B. INSTITUTE OF ENGINEERING & TECHNOLGY, JNTU
Intermediate - undefined
New Vision Junior College, IPE
SSC - undefined
Nagarjuna High School, SSC
Skills
Strategic Planning
Talent Development
Resource Allocation
Cross-Functional Collaboration
ISO 13485
ISO 14971/24971
ISO 10993
IEC 60601
IEC 62366-1
Additionalinformation
English, Hindi, Telugu, Exploring and gaining knowledge about topics of interest on the internet, Knowing about new technologies, Watching movies & TV, Participated and won 3rd prize in Technical Paper presentation on “Magnetic Power”, Presented a paper at MGIT college on “Cyber Crimes”., Active member of “Rotary club of Hyderabad”., Participated in Workshop on “MEDICAL IMAGING” at IIS BANGALORE., Good communication skills., Excellent organizational abilities., Equipped to work and lead a team., Rational approach to problem-solving., Self-motivated and risk-taker., Accountable
Personal Information
- Date of Birth: 11/12/89
- Gender: Male
Projects
Voice Actuated Hospital Bed Control and Heartbeat Monitoring and Alerting Systems, The main aim of this project is to design and construct a voice operated hospital bed control system along with electrical devices. This system acts as human-machine communication system. Speech recognition is the process of recognizing the spoken words to take the necessary actions accordingly.
Disclaimer
I hereby declare that the above-mentioned information is correct to my knowledge, and I bear the responsibility for the correctness of the above-mentioned particulars
Certification
ISO 13485
Timeline
Senior Manager – MedTech Regulatory Affairs
Techsol Lifesciences Pvt Ltd
11.2022 - Current
Design Quality Engineer
Cyient ltd.
12.2020 - 11.2022
Team Lead-Global Regulatory Services
Freyr Solutions services private limited.
01.2019 - 12.2020
Biomedical/Medical Device Engineer
Makrocare Clinical research ltd.
06.2017 - 12.2018
Application Engineer
ESAOTE INDIA (NS) ltd.
12.2012 - 06.2017
Service Engineer
TEES Medical Systems
06.2011 - 11.2012
B. Tech (BME) -
J.B. INSTITUTE OF ENGINEERING & TECHNOLGY, JNTU
Intermediate - undefined
New Vision Junior College, IPE
SSC - undefined
Nagarjuna High School, SSC
ISO 13485
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