{"id":3555,"date":"2022-12-22T11:04:52","date_gmt":"2022-12-22T11:04:52","guid":{"rendered":"https:\/\/proqc.com\/blog\/?p=3555"},"modified":"2022-12-22T11:05:52","modified_gmt":"2022-12-22T11:05:52","slug":"what-is-medical-device-single-audit-program-mdsap","status":"publish","type":"post","link":"https:\/\/proqc.com\/blog\/what-is-medical-device-single-audit-program-mdsap\/","title":{"rendered":"What is Medical Device Single Audit Program (MDSAP)?"},"content":{"rendered":"

Medical Device Single Audit Program (MDSAP)<\/h2>\n

An MDSAP is a type of audit that focuses on the medical device industry. It is a voluntary program that helps companies to improve their quality management systems and comply with international standards. The program is based on ISO 13485<\/a>.<\/p>\n

What is MDSAP?<\/h2>\n

The Medical Device Single Audit Program (MDSAP) is an international program that harmonizes the requirements for a quality management system (QMS) audit of medical device manufacturers. The program was developed by the International Medical Device Regulators Forum (IMDRF) in order to streamline the process of QMS audits for companies that manufacture medical devices that are sold in multiple jurisdictions. <\/p>\n

The European Union’s Notified Bodies. MDSAP was implemented on January 1, 2016, and the first audits were conducted in 2017. As of 2019, all six participating authorities require MDSAP certification for medical device manufacturers that wish to sell their products in their respective jurisdictions.<\/p>\n

What is the difference between ISO 13485 and MDSAP?<\/h2>\n

There are a few key differences between ISO 13485 and MDSAP. <\/p>\n

ISO 13485 is a quality management system standard specific to medical device manufacturers. It is voluntary though encompasses recommended best practices for manufacturers to adopt.<\/p>\n

MDSAP is an audit program that aims to streamline regulatory compliance from different countries, such as Australia, Brazil, Canada, Japan, and the US, making it easier for medical device manufacturers. MDSAP registration is required to sell medical devices in these markets.<\/p>\n

ISO 13485 is focused on quality management within an organization, while MDSAP takes a more holistic approach to compliance, covering audits, device labeling, and post-market surveillance.<\/p>\n

Which country is MDSAP mandatory for?<\/h2>\n

There are currently five regional market regulators who have adopted MDSAP: <\/p>\n