Xybion provides a suite of integrated solutions specifically designed for Medical Device manufacturing companies. With a combination of software technology and value-added services including complete systems and process validation, Xybion is well positioned to be your partner in helping mitigate regulatory compliance risk while decreasing operational costs associated with running your Medical Device business.
Unique solutions for unique challenges
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.
Xybion can help your company in a number of ways including:
- Create and support a consistent compliance and quality management program globally
- Reduce compliance risk and associated costs
- Improve batch to batch consistency in the manufacturing & fabrication process
- Improve the efficiency of systems, plant and equipment maintenance
- Reduce overall costs related to quality & compliant
Xybion provides a full suite of integrated quality & compliance solutions that can help your enterprise operate more efficiently and with a lower overall risk of operating out of compliance with the FDA.