Rupali Kumar is a Regulatory Affairs Consultant at AlvaMed with experience in the preparation and submission of medical device regulatory submissions. Rupali is adept in providing valuable regulatory and clinical support to clients.

Rupali’s accomplishments include:

  • Provided regulatory expertise to develop a tailored strategy to a medical device company seeking to determine the classification of their medical device and to identify the best regulatory pathway to obtain FDA approval to bring to market. This project included conducting FDA database searches, literature evaluations, and thorough examinations of guidance documents to identify predicates and classification of the device.
  • Developed comprehensive regulatory plans for clients, conducting meticulous research and analysis of regulatory requirements.
  • Assisted in the preparation and formatting of a 510(k) submission for a client seeking to bring their Endoscope Accessory Overtube to the US market.
  • Contributed to the preparation and review of technical files and drafted various regulatory documents, including Investigational Brochures, 510(k) summaries, and pre-submission meeting request applications. Provided meticulous compilation and organization of complex regulatory information while ensuring that the submission documents met all regulatory requirements.
  • A client, which is a leading US-BASED global medical aesthetic device company that provides advanced energy-based solutions for a broad range of medical-aesthetic applications, were seeking AlvaMed’s assistance to develop a Clinical Evaluation Report (CER). Rupali conducted extensive literature searches across multiple databases, including EMBASE, PubMed, Cochrane, and Google Scholar, to gather pertinent information for the CER. Applied rigorous research and evaluation techniques to evaluate over 1,000 literature searches for the CER. She utilized Appraisal-Suitability criteria and Benefit/Risk analysis methods to identify the most relevant articles.
  • Trained in quality system internal auditing to ISO 13485:2016.

Rupali holds a Master of Science in regulatory affairs from Northeastern University and a Bachelor’s in pharmacy from Manipal University. She has also authored two articles that have been published in International Journal of Health Planning and Management & Indian Journal of Psychiatry.