COMPANY BACKGROUND
Founded in 2008, First Medical Source (FMS) is committed to leverage its management capability and its reliable supply network to deliver excellence in Infusion Therapy, Contract Manufacturing and QA/RA Consulting to surgery centers, and medical device manufacturers..
Since its birth FMS has served its customer needs in the US and across the world with FDA compliant, high quality, low cost elastomeric infusion pumps, anesthesia kits, QA/RA consulting and sterile device contract manufacturing.
LEARNING FROM OUR SUCCESS
Key to our success and to our unbeatable reputation of quality, and on time delivery is our pioneering work in quality and our experience in risk based approach to management. We establish a framework that facilitates access to information, simplifies work, and provides guidance to suppliers, engineers and product/program managers to rapidly move projects from concept to delivery within the regulatory constraints.
FOUNDER'S BIO
Mark co-founded Curlin Medical, and managed its quality, regulatory affairs, and supply chain. Following Curlin's acquisition by Moog, Mark founded First Medical Source (FMS) and led the FDA clearance of an elastomeric pump, later acquired by B Braun and rebranded as EasyPump®.
Since 2010, Mark has been manufacturing and distributing pain management kits, and has consulted on risk mitigation for sterile disposables and Class II & III electromechanical devices, covering design, validation, manufacturing, and post-market surveillance. His project leadership includes work on heart valves, heart pumps, infusion pumps, hemodialysis machines, patient monitoring systems, glucose monitoring systems, ventilators and neonatal phototherapy devices.
In November 2024, Mark achieved clearance for InfuLife®, an elastomeric pump featuring a patented design that enhances accuracy and reduces leakage.
Mark holds a Ph.D. in Probability and Statistics, an M.S. in Stochastic Control, and an M.S. in Mathematical Engineering from the University of Sciences, Paris, France. He is fluent in French and German. His approach, centered on building system coherence, transparency, and flexibility, strategically leverages resources to boost quality, compliance, productivity, and competitive positioning.
GM'S BIO
Kurt offers over three decades of experience in the medical device industry. He has a clear focus on mitigating risk in product design, tool design, manufacturing processes, and offshore transfer of products. His passion for excellence applying quality management system is relentless.
Kurt's experience covers startups as well as multinational organizations, realizing products such as:
- Cardiopulmonary blood oxygenators, cardiotomy reservoir and arterial filters, cardiac occlude and percutaneous transcatheter sets
- Drug delivery systems – electromechanical and single use elastomeric infusion pumps, IV sets, catheters, drug bags
- Ventilator devices and delivery lines.
Kurt regularly applies his degree in mechanical design and manufacturing to improve products quality, safety and efficacy.