Steven Lowrance, MS, PhD has 10 years of bench science experience as a Neuroscientist, specializing in neurodegenerative diseases and stroke. He transitioned to the medical device industry in 2015 as a Medical Writer for Cook Research, Inc. (a Cook Medical Company). He joined NAMSA in 2019 as a Principal Medical Writer, specializing in writing clinical evaluation reports (CERs) for high-risk devices and tasked with assisting with our most challenging projects. Steven recently completed a post-graduate certificate program in Biotechnology and Regulatory Compliance at Purdue University’s College of Agriculture and Biological Engineering (Lafayette, IN). This program focused on U.S. Food and Drug Administration (FDA) regulatory submissions for pharmaceuticals and medical devices, quality management systems and regulatory compliance. During this program, Steven was also certified as a Lean Six Sigma Yellow Belt.

CORE COMPETENCIES 

• EU Medical Device Regulation (MDR) transition strategies
• Preparing and reviewing CERs to MEDDEV 2.7/1 Rev 4 and MDR requirements, including MDCG 2020-5 and MDCG 2020-6
• Authoring over 60 CERs in clinical areas, including aortic intervention, peripheral intervention, surgery, interventional radiology, urology, critical care and endoscopy
• Authoring multiple stand-alone literature searches to support neurology, aortic intervention, lead management, critical care, interventional radiology and peripheral intervention products
• Performing gap analyses of regulatory and clinical strategies, submissions and key documents to the EU Medical Device Directive (MDD) and MDR
• Published peer‑reviewed publications, presented at scientific conferences and taught multiple scientific college courses as the instructor of record
• Extensive experience with non-GLP preclinical study design and execution; protocol development; data management, analysis and interpretation; generation of conclusions; and communication of findings
• Extensive understanding of research design and implementation, including: a) design and execution of multiple preclinical studies using rodent models of degenerative disease, stroke and chronic stress; 2) conduct of therapeutic interventions, including small molecule (substituted pyrimidines) and biologic large molecule (mesenchymal stem cell) research; and 3) led multiple projects simultaneously, coordinated study logistics, managed resources and mentored student research teams

RECENT PROJECTS

• Updating CERs from MEDDEV 2.7/1 Rev 4 to MDR requirements in the following therapeutic areas: peripheral intervention, interventional radiology, endoscopy, otolaryngology, bone autograft and allograft