How does the MDSAP ensure medical devices are manufactured in accordance with multiple jurisdictional regulations?

The MDSAP relies on:

• Annual audits of manufacturers according to an audit approach specific to the program. This audit approach was developed to review the compliance of a manufacturer’s quality management system (QMS) to the international standard ISO 13485 and additional regulatory requirements applicable to the countries where the devices are sold; and
• Annual assessments of the AOs’ management system compliance to the international standard ISO/IEC 17021-1 and MDSAP specific requirements as defined in IMDRF MDSAP WG documents.