I’m a dentist turned regulatory professional with deep clinical knowledge, helping medical device companies navigate EU MDR, FDA, CDSCO pathways with clarity and confidence: ensuring compliant documentation, strong clinical evidence and smooth market access. My work focuses on turning complex regulatory and clinical requirements into clear strategies, high-quality reports within timelines. Whether it’s a new device, a legacy product, or a Global portfolio, I support companies in reducing uncertainty and strengthening their compliance foundation. Over the past years, I’ve supported manufacturers, startups, and MedTech teams with: • Clinical Evaluation Reports (CERs) under EU MDR, FDA, CDSCO • Literature reviews and clinical evidence synthesis • PMS and PMCF planning, reporting, and data evaluation • Regulatory strategy and technical documentation for EU submissions and other global pathways • Market entry guidance for multiple countries and regulatory jurisdictions • Predicate device and substantial equivalence assessments during design integration • Support during the design and development phase to align clinical, technical, and regulatory requirements • Risk management alignment with ISO 14971 • Technical documentation updates and gap closure • Cross-functional collaboration with R&D, Quality, Clinical, and Regulatory teams • MDSAP aligned audits and compliance assessments as an MDSAP certified auditor 📌My approach is simple: clarity, accuracy, and proactive execution: no surprises, no last-minute reworks, no compliance gaps, first time right. 📌If you need support with EU MDR clinical documentation, FDA submissions through regulatory pathway, CDSCO registration licenses and LAR, Global market entry for your medical devices, or smart regulatory strategy, feel free to reach out. I would be happy to help and take it forward. 📩 Message me anytime. Happy to connect and collaborate with MedTech teams to work towards safe, effective, and compliant devices as a regulatory consultant