Robling Medical, Inc. fulfills the needs of the medical device industry as a full service contract manufacturer. We provide the personnel, facility and “know how” to a wide range of customers in order to launch their products to markets around the globe. Our customers include established medical device companies, both small and large, as well as medical professionals, inventors and start-up companies. Our team has the expertise and experience to navigate the various governmental approval processes and to avoid design and manufacturing pitfalls and challenges. Robling will take your product from concept to market by providing product design for manufacturing input, assembly process design, manufacturing, packaging, sterilization and distribution. Each step of the process is performed following our high-quality design, development and production standards and comprehensive procedures and systems.
Robling Medical is an excellent outsourcing option among medical device contract manufacturers. Our technical qualifications:
- FDA Registered as Contract Manufacturer and 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
Contact Robling Medical today to see how we can help you take your medical device to market. Call us at (919) 570-9605 or send us an email.
At Robling, we are committed to providing services and products of the highest level of regulatory and specification compliance in a timeframe that surpasses our competition. When time to market is critical to the success of your business, Robling is your solution. With over 20 years of experience defining, developing and executing each step of the product lifecycle, Robling can transform your designs into reality utilizing our mature, tried and true infrastructure of design validation, verification and manufacturing processes. Using the latest assembly and packing technologies, Robling can boost your productivity and reduce assembly costs in this highly competitive market.
Because of our broad range of experience and expertise, some of the advantages of selecting Robling Medical as your contract manufacturing partner include:
- Navigating the often complex path of government regulations, submissions and approvals: allowing our customers to focus on new designs and marketing of their product.
- Offering valuable suggestions and recommendations, and avoiding the common pitfalls and obstacles we have seen during product launches that cost time and money.
- Charting and tracking milestones and tasks, to assure open communication and visibility towards our common goal of an on-time scheduled launch of your product.
- Continuous searching for areas of improvements and risk reduction. A proactive closed loop Post Market Surveillance Program assures that market feedback is sought and analyzed and appropriately acted upon.
- Completely managing supply chain, contract manufacturing, and final device inventory control.
- Managing all validations and submissions, device history records, and approvals with the FDA, as well as foreign regulatory organizations.
At Robling Medical, Inc., we go beyond what is expected to ensure the highest level of excellence throughout every project. We do not accept compromise.
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. Our manufacturing and quality assurance systems, as well as our trained staff, are flexible and easily adapted to a broad spectrum of contract manufacturing operations. We offer a wide spectrum of contract assembly capabilities that range from simple subassemblies to fully assembled and packaged/sterilized complex medical devices that are ready for the operating environment. We provide:
- Custom design and validation of fixtures and assembly equipment as a means of delivering consistent, efficient, cost effective assembled devices
- High volume medical tube tipping, skiving, drilling, punching and custom processing, to meet your specific catheter requirements
- High speed automated packaging equipment, for low cost, high volume projects
- Custom medical bag manufacturing for many types of closed-loop fluid handling projects
- Various types of bonding methods with capabilities including UV, solvent bonding, and heat staking
OUR REGULATORY QUALITY SYSTEMS
Robling Medical, Inc. is a U.S. FDA registered facility, ISO9001, and ISO13485 certified 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 core capabilities make us an excellent fit for:
- Minimally invasive devices/procedures
- Highly specialized custom medical tubing
- Electro-mechanical, single-use surgical devices
- Procedural kits
- Medical bags with delivery tubing attached for blood collection, fluid delivery or waste collection systems
- Fluid (Liquid or Gas) Delivery
- Guide Wire
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.
We recognize that when our customers make the difficult decision for selecting the next contract manufacturing partner, the results of their choice will affect the performance of their company and possibly impacts to their careers. Robling Medical shares directly in the goals of our customers, to bring the best possible product to market, on time.
Contact Robling Medical today to see how we can help you get your medical device to market. Call us at (919) 570-9605 or send us an email.