Robling Medical, Inc. caters to the special needs of the medical device industry as a full service contract manufacturer. Our comprehensive procedures and systems take your product from concept to market ensuring only the highest quality and standards are adhered to every step of the way. Robling Medical was started by Brent Robling, founder of Apogee Medical.
Robling sold Apogee Medical to Hollister of Libertyville, Illinois in 2005 and continued to manage operations as President of Apogee Medical. With Hollister’s recent decision to exit the contract manufacturing business, Robling again entered the market as Robling Medical, Inc. to ensure that quality contract manufacturing facility services would still be available. Robling and Hollister entered into a long-term supply agreement with Robling manufacturing certain Apogee and Hollister branded urology products.
Robling brings extensive experience and background in the contract manufacturing industry, along with a commitment to help medical professionals and start up companies navigate the government approval process and avoid manufacturing pitfalls.
Robling Medical is an excellent choice as an outsource option among medical device contract manufacturers.
- FDA Registered as Manufacturer, Specification Developer, Distributor
- 21 CFR Part 820 – Quality System Regulation Compliant
- ISO 9001:2008 Registered
- ISO 13485:2003 Registered
- CE Marking Capabilities
- Japanese Pharmaceutical Law (JPAL) Registered for Disposable Medical Devices
- Canadian Medical Device Conformity Assessment (CMDCAS) compliant
- Canadian Medical Device Licensing Capabilities
- Capable of obtaining various Foreign Government Regulatory clearance/approval
At Robling, we are committed to boosting productivity and reducing assembly costs. We improve your ability to deliver competitive products by giving you access to the latest in assembly technology. Manufacturers of a diverse range of medical devices have found Robling Medical’s technology indispensable in reducing processing time, lowering per unit costs, improving overall product quality and providing an avenue for new and innovative design solutions.
When choosing a contract manufacturer, criteria such as facility, equipment, and experience take priority to ensure a good match. With this and more, Robling will meet and exceed all your needs and expectations. Our expertise enables us to fulfill prototype and short runs, as well as offer full production capabilities, giving your company a competitive manufacturing edge. Because each project is unique, we answer your needs by providing innovative solutions to specific problems. This gives our customers the ability to compete in their chosen markets without having to establish the same critical systems in their own facilities.
At Robling Medical, Inc., we go beyond what is expected to ensure the highest level of excellence throughout every project. We do not accept compromises.
OUR FACILITIES & EQUIPMENT
Our state-of-the-art facility is equipped with 15,000 square feet of cleanroom space designed to meet the needs of a variety of medical device manufacturing requirements well into the future.
Disposable assemblies have been proven to reduce the risk of contamination and provide a safer healthcare alternative. In many cases, a disposable assembly may also be less expensive. Robling Medical will customize disposable assemblies for your specific application. These may include connectors, valves, tubing, containers or filters. We manufacture to FDA and ISO standards and use the latest technologies and validated processes to ensure the highest quality of disposable devices.
Automated assembly allows us to better control our processes and, as a result, maintain cost efficiency.
Our operating, manufacturing and quality assurance systems, as well as our trained staff are flexible and easily adapted to a broad spectrum of contract assembly operations. The contract assembly activities may be as simple as a single assembly or labeling operation of a component or subassembly to total fabrication, packaging, contract sterilization and distribution of a finished device.
OUR REGULATORY QUALITY SYSTEMS
Robling Medical, Inc. is a U.S. FDA, ISO9001, and ISO13485 registered manufacturer. Robling Medical aggressively pursues excellence by continually refining, monitoring and perfecting our processes, which ensures that we are exceeding the industry standards and, by doing so, consistently producing a superior product.
It takes more than the right equipment, facility and knowledge to be a good business partner. It takes a good working relationship to build a sense of confidence that the job will be handled professionally.
Our organizational structure facilitates personal service and customer responsiveness. We understand what “customer responsiveness” truly means, and strive to build a relationship that is reinforced through every step of the project. Our management operates as a cross-functional team during the life cycle of a project, particularly during product development and quality improvement initiatives.
While our standards are high, our overhead is low. An efficient internal organization and comprehensive understanding of the industry aids us in offering more flexibility than other contract medical device manufacturers. We offer quick turnaround times and competitive pricing, as well as strategic planning and ramp-up capabilities.