品質管理
Therefore, organizations that import, sell or otherwise distribute Class I patient management software must have an establishment license and Class II patient management software must have a medical device licence. In order to obtain a medical device licence, manufacturers must hold a quality management system (QMS) certificate issued by an accredited registrar showing that the QMS is compliant with ISO 13485: 2003 Medical devices – Quality management systems – requirements for regulatory purposes. Organizations are also required to perform certain post-market responsibilities such as maintaining distribution and complaint handling records, mandatory problem reporting and recalls.