Pain Pumps, Contract Manufacturing, and QA/RA Consulting Services Worldwide
THE COMPANY

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

For the past 20+ years, Mark Shal provides expertise mitigating risks through design, validation, manufacturing, and post market surveillance of sterile class II and III electromechanical devices. He has led projects in design and realization of heart valves, heart pumps, infusion pumps, hemodialysis machines, patient monitoring systems, and ventilators. Since 2017, he has compiled two EU MDR/2017 compliant technical files.
Mark holds a Ph.D in probability and statistics, an MS in Stochastic Control, and an MS in mathematical engineering from the university of Sciences, Paris, France. He is fluent in French, and German.
Mark's approach, focused on building system coherence, transparency, and flexibility leverages resources to improve quality, compliance, productivity, and competitive position.

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.


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