Medical DevicesNotified BodyRegulatory Information Management

1. ISO 13485:2016 and MDSAP Certification Services


Booth: 440

ISO 13485 is a medical device standard that was first published in 1996 by the International Organization for Standardization (ISO). The standard has been revised many times over the years (most recently in 2016). ISO 13485:2016 requires an organization that is in involved in one or more stages in a medical product’s life cycle, to prove that its quality management system (QMS) effectively and consistently meets customer and regulatory requirements. ISO 13485:2016 is the most extensively used international standard for medical device quality management certification and is accepted worldwide as a point of reference for quality management systems. Although ISO 13485 is established globally, there was a need to create an audit system that covered the aspects of ISO 13485 as well as regulatory requirements. Therefore, Medical Device Single Audit Program (MDSAP) was developed in 2012. It consists of 5 regulatory authorities (RA) from these countries: Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan, (PMDA & MHLW), and the United States (FDA) with South Korea and Argentina joining as affiliate members. MDSAP covers the requirements of ISO 13485:2016 plus the regulatory requirements for each nation and includes the Good Manufacturing Practice requirements. MDSAP is observed by the World Health Organization (WHO) and the European Union (EU). Before the MDSAP program, medical device manufacturers had to show their fulfillment of each country’s regulatory requirements within different and separate processes. Now, due to the work of the International Medical Device Regulators Forum (IMDRF), one audit will cover the regulatory requirements of all the member nations. The objective of MDSAP is to achieve a common audit standard by taking the different regulatory requirements of national approval bodies. Having an MDSAP certification provides a fast track into multiple markets, reduces time and cost of having multiple audits, and improves transparency in the industry. [TUV USA, Inc. also offers a variety of other standards. Please contact us for further information.]

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