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Premkumar Sivaraman

FC Associate at Amazon

I am an experienced professional with a strong background in Post Market Surveillance (PMS) document preparation and EU-MDR Regulatory Affairs. My expertise encompasses a comprehensive understanding of ISO 13485, EU-MDR, and FDA regulations, allowing me to ensure compliance and regulatory adherence in all aspects of my work.

Experience

FC Associate

Responsibilities:

Impact:

Medical Writer

Responsibilities:

Impact:

Verification Expert (Intern)

Responsibilities:

Impact:

overall quality of data.

Projects

missing mri pulse sequence synthesis using multi-modal generative adversarial network (2021)

  • medical device
  • regulatory affair
  • team management
  • trend analysis
  • communication
  • quality management system
  • quality assurence
  • kyc process
  • document verification

Financial Analysis of Medical Device Development and Commercialization: A Case Study Approach

its commercialisation. The study also focuses on the formulation of cost-reduction strategies for healthcare organizations engaged in the manufacturing of medical devices. Application of automation and update is highly effective in order to minimize costs related to medical device development as it reduces 30% of operational costs of Healthcare organizations including Abbott Laboratories and Philips Laboratories

Awards

Customer Appreciation Award

Received the Customer Appreciation Award from Tata Elxsi Pvt Ltd in April 2022 for outstanding performance in delivering client projects within deadlines, demonstrating a commitment to customer- focused excellence.