ISO 13485 Certification  
  Business Challenge

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. Based on ISO 9001, the emphasis on continu- al improvement is replaced with an emphasis on meeting regulatory and customer requirements, risk management, and maintaining effective processes, namely the safe design, manufacture, and distribution of medical devices.
It is important to note that being certified to ISO 13485 does not fulfill the requirements of either the FDA or foreign regulators; however, the certification provides a solid framework on which to build compliance to various regulatory and customer requirements.