Regulatory:

Quality First International is a leading, global medical devices consultancy, with extensive insight and business know how in the medical devices regulatory field. QFI is committed to solving your regulatory, technical and compliance challenges to enable your medical device to enter the global marketplace. With our technical expertise, accuracy and confidentiality we can help you be the first to market, reinforce the approval of your medical device, resolve any compliance issues and solve other problems encountered during the regulatory approval of your medical device.

Manufacturing:

C2M offers a full service solution for your Contract Assembly Services Requirements. From Prototype to Production. We are a ISO 13485:2003 and 9001:2008 registered manufacturing facility. Our IPC 610D Certified process incorporates Leading Edge technology for uBGA - 0201 and ultra fine pitch. The manufacturing processes are backed up by Computerized Automatic Optical inspection and a best in class Tetesting and Repair Depot. Kimball’s Medical Solutions group provides global  mandated ISO 13485 manufacturing and assembly for a broad range of clientele and products. Jabil's worldwide medical manufacturing facilities meet and even surpass the most stringent standards that U.S. and European Union regulatory bodies mandate. Quality and reliability are critical for this industry, and Jabil has a stellar track record of consistently manufacturing and repairing products on time, all around the world. With more than half of its medical and instrumentation customers manufacturing lot sizes of 50 or fewer, Jabil is structured to support the high-mix, low-volume needs specific to this industry. Covidien is a $10 billion dollar company with market-leading products that help medical professionals deliver a high standard of care. Whether surgical solutions, vascular therapies, respiratory and monitoring products, pharmaceuticals or medical supplies, our products support our customers' success and improve patient outcomes.  Covidien supplies our SnapPad Gel Pads and has been instrumental in various phases of the product R&D. Florida Custom Mold is a recognized leader in Prototype to Production Molds and Injection Molding of Thermoplastic Materials in Low to Mid Volume Quantities. FCM has developed a technical expertise and established a broad base of experience in designing and developing custom molds as well as plastic injection molding of parts, setting it apart from other companies in this market.

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