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 ISO 18969, and liaison with the EU Commission – Clinical Investigation and Evaluation (CIE) task force and other regulatory authorities throughout the world.

Marco has more than 10 years of experience in the medical device industry and more than 3 years in the information communication technology (ICT) and automotive industry.

Regulatory affairs: Certified regulatory associate experienced in formulating regulatory pathways for EU, and USA market access; experienced in review of technical documentation for gap analysis and technical submissions to regulatory authorities and notified bodies. Experience such as Person responsible of MDR (Art.15) in order to verify the requirements of regulation.

Quality assurance: Supported third-party internal audits for QMS (manufacturing) and participated in external audits for CE-mark approval. Process owner for the Design Control (DC)/change process for medical device development according to ISO 13485 and the Product Risk Management (RM) process according to ISO 14971. Internal audit for the role of person responsible of MDR (art 15), according to ISO 9001 and MDR 2017/745. Review, writing and approval of technical dossier according system operation procedure. Sound understanding of quality system management and review, CAPA, FSCA, audit, supplier management.

Clinical experience: Writing, compliance review and release of clinical evaluation plan (CEP) and reports (CER) & post-market clinical follow-up activities (PMS, PMCF, PSUR, SSCP) (MDR, MEDDEV 2.7.1, MEDDEV 2.12.2, ISO 14155, and MDCG guidance). Clinical investigation experience in medical device field according to ISO 14155:2020 (medical writing, monitoring, audit, site selection, communication with competent authorities and ethics committees, management of supplier CRO). Experience with medical writing of medical article published in international journal obtained during PhD in Cardiovascular Physiology and post-doc activities.

With over 15 years of experience in the clinical research industry Ms Emma González is Senior Project Manager and handling the planning and resourcing of CRA team at MD-Clinicals.

Providing strong therapeutic experience in several areas and successful project management including resourcing planning, budgeting and coordination. She worked across various therapeutic fields, including Oncology, Cardiovascular, Haematology, Central Nervous System, Endocrinology, Cardiology, Periodontology, Rheumatic disease, and Spinal cord injury.

Since 2019 she is also acting as Safety Manager within the scope of MDR, ensuring timeline reporting and main liaison communication line with regulatory authorities, hosting training of internal team members and guidance to clients on safety topics.

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. Li Xin has a extensive understanding of the Chinese medical device GCP standard and the international medical device GCP (ISO 14155) , she has an experience in early product regulatory path planning and clinical feasibility analysis of China clinical data for overseas market access. She worked across various therapeutic fields, including cardiology, psychiatry, ophthalmology, endocrinology, neurology, and surgical hemostasis. As a speaker, she has shared Chinese regulations and clinical and regulatory strategies for Chinese device overseas market access at international conferences.

Her talents in overcoming culture barriers and communication differences make her an important asset to any clinical project involving China. Effectively assisted Chinese medical device enterprises in quickly and effectively conducting overseas clinical trials and registration.

I am Yatma Sarr, an accomplished biostatistician with over 10 years of dedicated expertise. I earned my degree in Mathematics and Statistics applied to Life Science from Paris Descartes University and recently obtained certification from Harvard University in Methods & Applications applied to Biostatistics.

In recent years, my professional focus has centered on the dynamic landscape of medical device Clinical Research Organizations (CROs). Throughout my career, I have developed specialized skills in biostatistics, particularly in the design and analysis of complex clinical trials within the medical device sector. I have contributed significantly to the success of projects across various phases of clinical trials in this specialized field.

Beyond my expertise in medical device research, my skills extend to broader domains such as oncology, data science, research and development (R&D) including DNA and RNA sequencing among others. My commitment to precision and excellence, coupled with a keen analytical mindset, positions me as a valuable asset capable of navigating the complexities of statistical analysis. With a professional approach characterized by an open-minded perspective, I am eager to leverage my experience to contribute effectively to the success of future endeavors across diverse fields.

Ms. Popy is a certified pharmacist. She brings extensive experience in drug and medical device research to her role as a Clinical Quality Assurance Associate. Her diverse skillset encompasses monitoring, quality control, project management, and audits, honed through practical experience.

Dedicated to excellence, Ms. Popy holds certifications in ISO 9001:2015 and ISO 14155:2020, demonstrating her commitment to upholding the highest standards. As a multilingual individual (English and Indonesian), she fosters collaboration and innovation within diverse healthcare teams.

In her role, Ms. Popy ensures the quality of internal systems and project operations, maintaining compliance with regulations. She conducts and prepare thorough audits and inspections, meticulously managing documents and safeguarding the integrity of clinical data. Additionally, she analyses and improves processes, driving efficiency and effectiveness across the board.

Hwee Ee has close to 40 years of work experience in QA & RA roles the medical device industry. Her career stated in the manufacturing industry and in both QA & RA roles and held positions as Engineer and as Senior Manager. She is a member of Working Group 7 (WG7) – Quality Management System – of the Global Harmonization Working Party (GHWP).

Hwee Ee is the Co-founder and Principal Consultant for DH RegSys since 2010. She focuses on the areas of including Quality Management System (ISO13485‐2016 and 21CFR Part 820); product quality assurance (QA); and regulatory requirements of countries for product registration such as Singapore HSA, Malaysia MDA, Australia TGA, US FDA, European EU MDR and IVDR. Besides these advisory services, Hwee Ee has been actively involved in conducting training, both public and in-house training.

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