ISO 13485 

McAllister Consulting assists medical device manufacturers in meeting ISO 13485 requirements and preparing for ISO registration. Those involved in the medical device supply chain, including component manufacturers, can move directly to ISO 13485 registration, or can add ISO 13485 requirements to their existing ISO 9001 registration. McAllister assists clients in both types of projects but encourages “blending” ISO 9001 and 13485 quality systems to achieve maximum integration, while avoiding costly duplication of procedures and practices. ISO 13485 systems can include relevant FDA requirements, thus satisfying the needs of American medical industry customers. Requirements for the CE Mark, a designation often required on product headed for the European Union, also can be rolled-into ISO 13485 efforts. Phone McAllister Consulting for details.