The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of quality management systems (QMS) of manufacturers of medical devices.
The MDSAP audit is based on ISO 13485:2016. A tracked changes version of a Standard indicates the changes made, during the standards revision process, between the active standard and its previous version. Additions, deletions, and other formatting and/or content revisions are clearly displayed as underlined and strikethrough texts, ensuring all changes made between the two documents are quickly and easily identified.
What is this standard about?
As an International Standard, ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.
Requirements of ISO 13485:2016 are applicable to organisations regardless of their size or their type, except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organisation.