In-Vitro Diagnostics

Global’s Medical Device & IVD Team specializes in Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR). We are comprised of over 30 US-based full-time subject matter experts who started our careers at the bench and in the clinical laboratory, with subject matter expertise in medicine, pharmacy, molecular biology, cancer biology, biochemistry, physiology, toxicology, neuroscience, and more. Our writers are deeply familiar with the applicable regulations and most up to date guidance from the notified bodies. We regularly help leading medical device manufacturers navigate the uncertain waters of MDR and IVDR as well as the unwritten expectations of the regulatory authorities and the notified bodies (NBs). Our experts will identify obstacles and provide clear and actionable recommendations, from detailed gap analyses and complex mitigation plans to managing and handling the remediation of your full portfolio.


Our team began remediating EU technical documentation in 2015 and have been at the forefront of the MDR and IVDR transition. Each year, we average over 100 successful projects related to EU CE marking, including new product submissions, annual updates, remediations, and regulatory responses and negotiations. All work is completed in house and never outsourced, and you will have direct access to our writers to discuss your medical device or IVD device project as needed. All deliverables go through a rigorous internal quality control review to ensure that the conclusions are accurate and that the presentation is flawless. If provided, we will follow your templates, procedures, and style preferences. And if these do not exist, we are qualified to help you set up appropriate MDR/IVDR SOPs, WIs, and templates. It is for these reasons that Global has established itself as an industry leader and preferred vendor.