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.
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 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.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.