MEDICAL

Meeting industry and customer requirements

Meeting legislative regulations and customer requirements for the manufacture and sale of medical devices in a global marketplace can be confusing. With so many regulations, differing from country to country, an organization must address a complex array of quality, process, and management issues in order to compete internationally.

ISO 13485 defines the requirements that medical device manufacturers must incorporate into their management systems in order to achieve compliance in the medical device industry. Certification to this standard provides a solid framework on which to build compliance to various regulatory and customer requirements.