February 1, 2018

Medical Production & Regulatory Compliance

                Among the many strategic partners with which a medical device company can choose to work with to help them take their product(s) from design to reality, there is a myriad of criteria that sets each of them apart. Some only provide specialties such as tubing or metal components, some can have a range of capabilities to serve general industrial needs; and some, like Sanbor Medical, choose to exclusively focus on the medical market and offer our contract manufacturing services only to companies in the medical industry. 

        At Sanbor Medical, we make the conscious choice to exclusively serve medical device businesses for a few reasons: First, we believe by focusing our training, production and quality assurance on this single, innovative market, our team of dedicated personnel has the chance to elevate their expertise in this field while accumulating hands-on experience in an industry that exists to improve lives. 

       Second, we are more than equipped to handle the required necessities to produce the advanced designs our clients bring to us. Sanbor Medical has been in the medical industry for more than 20 years, and throughout these two decades, we have accumulated invaluable experience that only comes from being a steady participant in the medical market for such a long time. We have worked with many big name corporations and manufactured their designs not only to their exacting standards, but to the  FDA's as well. 

          Third, we trust that only by exclusively serving the medical industry, can we enable ourselves specific capabilities and compliance knowledge that a general contractor may never have the chance to encounter. Sanbor Medical prefers Class I and II finished devices, and Class I, II and III subsystem assemblies which are manufactured in our FDA registered facilities. Our production facilities are QSR compliant. We are proud to say that Sanbor Medical built its first ISO system in 1998. In 2005, we became ISO 13485 certified and FDA registered. We are currently certified to ISO 13485:2016 standards. One of our factories is complete with a clean room and all  fully adhere to the 21 CFR Part 820 Regulations for DHR and DMR maintenance. 


 Medical staff needs to be very careful when inside a clean room. With our high standards, Sanbor Medical and its qualified, dedicated team are more than excited to see what our next project will be. If you're a medical device OEM and are ready to team up with Sanbor Medical to produce your next high-quality device, contact us to learn more! 

Our helpful US HQ, located in Allentown, PA, would be happy to connect you to our facility. Potential clients are more than welcome to tour our factory, confirm that all of our certifications are up to date and see our passionate employees that thrive on being a part of something that can help a great deal of people. 

                Sanbor Medical believes in the quality of our top-notch services and our past customers can definitely testify that they were more than  satisfied with our thorough services throughout the entire manufacturing process. Our dedicated team is always excited to hear from you about any potential design(s) and is eager to let you know how we can help in turning your design into a finished product. We are ready to help people who have been desperately waiting for such a device! Don't hesitate to click any numbers or Contact Us links on the page or just press the button below to get in touch with our team, and let us see how we can best assist you! 

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