About

With a M.Sc.-Ph.D. in Biotechnology, from IIT-Bombay and a strong foundation in Healthcare IT, MedTech, PharmaTech Digital Solution and Regulatory affairs, I specialize in bridging healthcare innovations with digital transformation. My expertise lies in medical device interoperability, integration, regulatory compliance (EU MDR, FDA, HIPAA), and digital health solutions. I bring a unique combination of healthcare domain knowledge, regulatory documentation expertise, and strategic business analysis to develop and optimize medical technologies. As a Healthcare Domain Expert: I play a pivotal role in translating complex medical and regulatory requirements into IT-driven solutions. My responsibilities include: ✅ Healthcare IT Strategy & Innovation – Collaborating with stakeholders to design and optimize digital health solutions leveraging AI, ML, IoT, and cloud technologies. ✅ Regulatory Compliance & Medical Standards – Ensuring solutions align with HIPAA, FDA, EHR, and EU MDR standards while supporting medical device interoperability. ✅ Market & Competitive Analysis – Providing insights into healthcare data mining, UI/UX enhancements, strategic planning, and product positioning. As a Medical Writer: I specialize in regulatory documentation and literature review, utilizing platforms such as PubMed, Google Scholar, Embase, Cochrane, and MedWatch. My expertise includes: ✔️ Systematic Literature Review (SLR) – Developing SOTA and SD. ✔️ Clinical Evaluation Reports (CERs & CEPs) – Authoring regulatory documents to ensure adherence to EU MDR guidelines. ✔️ Adverse Event & Clinical Trials Analysis – Conducting research using EUDAMED, Health Canada, MHRA, TGA, and clinicalTrials.gov.