Team
Danielle Giroud
Founder, CEO
With over 30 years of experience, Ms. Danielle Giroud is an internationally recognized clinical research and regulatory expert within the global medical device industry. She has shared her extensive knowledge and experience with multi-national companies, organizations, and start-ups from around the world to help bring their products to market quickly and efficiently.
Ms. Giroud is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (WMDO), as well as convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155, and liaison with the EU Commission - Clinical Investigation and Evaluation (CIE) task force and other regulatory authorities throughout the world.
Tan Hwee Ee
Senior Consultant Asia, Regulatory & Quality Assurance
Ms. Tan has more than 20 years of experience in the medical device industry as a consultant, engineer, and senior manager. As an international expert in global regulatory compliance systems including 21 CFR part 820, ISO 13485, and Asia GDMP, she has successfully achieved numerous product certifications for clients from all over the world and accompanies your product development for market access throughout Asia, US, and Europe.
Ms. Tan has a wealth of regulatory and quality assurance expertise that she translates into comprehensive training courses whether in-house, online or at seminars. She is also a member of Working Group 6 (WG6) of the Asian Harmonization Working Party (AHWP).
Li Xin
Clinical Project Manager China
Ms. Li Xin is a certified medical device healthcare professional with over 18 years of healthcare experience and an accomplished liaison for market access in China. She is responsible for assisting clients to successfully place their products onto the Chinese market by establishing effective early-stage communications, performing GAP analysis, and help with qualifying Chinese clinical data for other world markets.
Her talents in overcoming culture barriers and communication differences make her an important asset to any clinical project involving China.
Ivon Septriyana, M.D.
Clinical Project Manager Asia Pacific
With over 15 years of experience in the healthcare industry, Ms. Septriyana is Clinical Project Manager for Asia Pacific (notably Indonesia, Malaysia, Singapore, Thailand, Taiwan, and Hongkong) and is responsible for clinical research set-up, site assessment visits, ethic committee and local regulatory submissions, monitoring visits, and document translations. Her therapeutic experience includes cardiology, obstetric gynecology, nephrology, ophthalmology, rheumatology, and psychiatry.
She is a member of the Indonesian Medical Association and the Indonesia Association for The Study of Medicinals (IASMED).