With over four years in Quality Assurance and Regulatory Affairs, I specialize in guiding medical device startups through compliance and quality management complexities. - Implemented comprehensive Quality Management Systems. - Secured manufacturing licenses for Class A to D medical devices. - Led successful external audits with ISO 13485 certifying agencies, CDSCO, and FDA. - Obtained regulatory certificates, including Free Sale Certificates and Trading Licenses (MD-42). Let's collaborate to ensure your medical devices meet the highest standards of quality and compliance