Seasoned Biomedical Scientist with over 15 years of experience in the MedTech industry. Proven track record of success in various aspects of the medical device/IVD industry, including research, product development, business, marketing, manufacturing, quality, and regulatory affairs. Throughout my career, I have successfully established two laboratories dedicated to the development of medical device/IVD products, collaborating closely with clients to achieve their market objectives. I hold certifications as a Lead Auditor and implementer for ISO 13485, ISO 14971, ISO 9001, ISO 17025, ISO 15189, and MDR/IVDR for CE marking, among others.