Robling Medical, Inc. Information

Robling Medical, LLC is a full service contract manufacturer. We rapidly take your medical device from concept to market around the globe using the highest quality standards. Our clients include established medical device companies, start-ups, medical professionals and inventors looking to outsource manufacturing of their medical devices. Robling Medical provides product design for manufacturing input, assembly process design, manufacturing, packaging, sterilization and distribution with each step of the process being performed within our high-quality design, development and production standards and comprehensive procedures and systems. Our team has the expertise and experience to navigate the various government approval processes and help you avoid design and manufacturing pitfalls and challenges. Why Robling? • 20+ years experience as a contract manufacturer for the medical device industry; • State-of-the-art facility with 15,000 square feet of cleanroom space and the latest assembly and packing technologies; • We navigate the complex path of government regulations, submissions and approvals for you; • Chart and track milestones and tasks, assuring open communication and transparency; • Completely manage supply chain, contract manufacturing, and final device inventory control; • Manage all validations and submissions, device history records, and approvals with the FDA, & foreign regulatory organizations; • Proactive closed loop Post Market Surveillance Program assures that market feedback is sought, analyzed and acted upon. Our core capabilities make us an excellent fit for: • Minimally invasive catheter based products • Highly specialized custom medical tubing • Electro-mechanical, single-use surgical devices • Procedural kits • Thermo-bonded medical bags with bonded tubing and ports • Ablation, balloon deployment, fluid or gas delivery, guide-wire controlled subassemblies and complete devices Learn more at www.roblingmedical.com.