Medical Devices

Medical Device manufacturers face a truly unique set of challenges, unlike traditional manufacturing companies. From preclinical development through post-approval marketing and the complete manufacturing process, Medical Device manufacturers must ensure the highest degree of consistency in their processes or risk potential sanctions from the FDA. Today’s medical devices are manufactured across the globe and can end up almost anywhere in the world. Manufacturers have complex regulatory, customs, excise, and security regulations to contend with, plus logistics can be a further challenge if, for example, cold chain storage end-to-end sterility is required.  Combined with these ongoing issues are the changing laws in Washington such as the affordable healthcare act and Medical Device Excise tax.