Regulatory Affairs Specialist Boise, Idaho Abigail Copeland is a Regulatory Affairs professional with a background in neuroscience and biomedical engineering. She draws on 9 years of experience in systems neuroscience research, complex data analysis, and scientific storytelling to support the development of innovative medical devices.

Auditing and QMS Development/ Maintenance services for Medical Devices, Medical Device Software, Laboratory, Clinical Trial services.

Regulatory Affairs Specialist Rockville, Washington DC Area Anya is a Regulatory Affairs professional with experience in international medical device compliance. Anya has led EU MDR transition projects, global submissions, and regulatory authority audits. She leverages her technical background and practical regulatory experience to help navigate complex regulatory landscapes. Anya has experience in:

• Dental devices
• Active therapeutic devices

David Davis is a nationally recognized reimbursement and market access executive with more than 25 years of experience helping innovative medical technologies achieve sustainable coverage, coding, and payment. As Founder and CEO of Market Access Experts, David partners with MedTech companies to navigate CMS policy, unlock novel payment pathways, and translate complex reimbursement challenges into executable commercial strategies

Dr. Emma Essock-Burns is a clinical product development leader and founder of Clinical Product Insights (CPI), a medtech strategy consultancy that helps teams translate complex technology into clinically adoptable, evidence-ready products. She combines strategic insight with hands-on operational experience applying the Stanford Biodesign Innovation process across medical imaging, digital surgery, mobility, and oncology. Dr. Essock-Burns is Assistant Director of the Stanford Biodesign Innovation Fellowship, holds a Ph.D. in Bioengineering from UCSF/UC Berkeley, and is currently pursuing an MBA at Santa Clara University’s Leavey School of Business.

Martin is a board certified in gastroenterology and a Fellow of the American College of Gastroenterology (FACG).  After his clinical practice, Martin was the Director of Gastroenterology and Endoscopy Devices for the FDA Center for Devices and Radiological Health (CDRH).

During the 10 years Martin was responsible for the clinical reviews of GI and endoscopy device from both start-ups to experienced medical device companies.   He reviewed medical devices in many other areas of CDRH, including but not limited to surgery, OB/GYN, nephrology, neurology and IVD.  He has expertise in evaluation of Q-Submissions, IDEs and HDEs, 510(k), De Novos and PMAs. He is very experienced in making presentations within the FDA (e.g., Panel Meetings) as well as national gastroenterology society medical meetings. He reviewed approximately 1,000 medical devices while working at CDRH.

Michael Bailey is the Managing Member of Catoctin Medical Device Consulting, LLC, which provides expert consulting services to companies planning or preparing FDA medical device marketing submissions. He is a medical device regulatory expert with 22 years of experience at the Food and Drug Administration (FDA), specializing in medical device review and policy assessment. During his tenure at the FDA, he served as the Team Lead of the Obstetrical and Reproductive Health Devices Team, Lead Reviewer in the Obstetrical and Gynecology Devices Branch, and Policy Analyst in the 510(k)/513(g) Program Operations Staff. He also served as the principle contact for assisted reproduction medical devices (prescription or home-use)

Pierre Floriano, PhD is an experienced MedTech consultant specializing in translational research and medical device development. He has worked in leading academic institutions such as the University of Texas at Austin, Rice University, and MD Anderson Cancer Center, as well as in the private sector. Pierre’s extensive portfolio includes more than 30 patents, 36 publications, and over $16M in federal and state grants, along with private funding, highlighting his significant contributions to innovation and research. Currently, Pierre provides strategic guidance to early-stage companies (www.comtexbio.com), assisting them with pre-clinical and clinical development efforts as well as non-dilutive funding strategies

Shreya Datta, PhD is an experienced MedTech professional, with primary focus on biological safety evaluation, manufacturing cleaning validation and reprocessing of medical devices. With over 20 years of combined experience in academia and the medical device sector, she has contributed to many 510(k), IDE and EU-MDR submissions of medical devices (Class I-III) including combination devices. Currently, she provides consultation to growing MedTech companies (www.sdbioservices.com) with pre-clinical evaluation to achieve regulatory success and compliance. She is also a committee member of the ISO/TC 150/WG 16 “Antimicrobial properties of implants