Sandeep Kumar

About Sandeep Kumar

I am a university graduate & trained medical device engineer with over 11+ years of extensive expertise in the medical device industry. I have substantial experience overseeing the whole medical device life cycle, from design to testing, manufacture, regulatory approval, and commercialization. I carry an extraordinary focus on detail and a profound dedication to ensuring and conforming to regulatory compliance. Regulation & Quality: Expertise in crafting and iterating quality management systems in accordance with ISO 13485 / Fifth Schedule, MDD / EUMDR, Indian MDR, and MDSAP. Quality system /SOP development, product lifecycle risk management, NCs/CAPAs, and trend analysis. Competent in analyzing and identifying medical device trends according to customer and regulatory requirements. Risk documentation and coherence of information throughout the dossier (TD, BSER, CER, Usability, etc.) as per ISO14971/24971. Expertise in crafting technical documentation for TGA, HSA, and IMDRF regulatory submissions across APAC and African markets. Biological evaluation: Effective completion of the biological evaluation plan and biological safety assessment report under ISO 10993, for borderline/Medical devices. Knowledge of the HI, MOS, and other methods for effectively evaluating and compiling data from supplier testing reports. Demonstrating biological equivalence in applicable cases, preparing and following methodology/protocol for literature searches, and pertinent considerations. Clinical Affairs: Clinical research study documents reviews & approvals, clinical evaluation (MDCG/MEDDEV), systematic literature search/appraisal, clinical risk-benefit analysis, SAE reporting, TMF audits for clinical research, staff training & development, and monitoring support. Proficient in conducting systematic reviews and using evidence-informed decision-making processes to influence clinical evaluations of medical devices. Expertise in evaluating health statistics data from credible sources, including medical journals like PubMed, Cochrane, and Elsevier, etc. Risk Management: Proficient in implementing ISO 14971 and ISO/TR 24971 & IEC/TR standards to effectively identify, assess, and mitigate risks associated with medical devices, ensuring compliance and enhancing product safety. Skilled in navigating IMDRF adverse event reporting protocols to promptly capture, document, and analyze incidents, enabling swift regulatory responses and continuous improvement in product performance.

Experience

1. Manager - Regulatory & Quality Control

   Vitrobio

   Dec 2021 — Present · IN

   Handling regulatory and QMS procedures to ensure compliance with ISO 13485, MDD/MDR, and MDSAP for regulatory alignment with organization objectives. Accountable for the classification of borderline medical devices as per MDR 2017/745, CE Marking procedure, compilation, and review of the MDR/MDD technical files and clinical reports improvements. Support and understand the regulatory compliance, gap analysis, remediation of the dossiers, clinical trials, adverse events, serious adverse events, and medical device documents including CER, PSUR, PMS, PMCF plan/report, data appraisal, and risk files. Responsible to perform rigorous systematic reviews of medical device clinical studies, using precise protocol (PICO, Search, Quality Assessment, Synthesize, Measure and Evaluate - Outcomes) and critical appraisal approaches to assess the safety, efficacy, and effectiveness of borderline medical devices. Adapted Evidence-informed decision-making frameworks to synthesize and analyze complicated data, resulting in practical recommendations for the use of medical equipment. Biological risk analysis, gap assessments, compliance initiatives, data review, protocol preparation/deviation management, hazard index and margin of safety, and dose selection. Implementation and preparation of the risk management reports, plan, and procedures as per ISO 14971. Usability risk assessment and reports preparation as per ISO 62366. Compliance check for packaging / labelling / promotional material. Designing and developing clinical study as per ISO14155 (study protocol, investigator’s brochure, test requisition form etc. Developing project-specific SOPs and data management tools. Review of literature articles analysis summarization of safety and performance field, AE data, and device-specific risks.

Education

• Deenbandhu Chhotu Ram University of Science and Technology (DCRUST), Murthal

  Bachelor of Technology (B.Tech.), Biomedical Engineering

  2009 — 2011