Medical Devices Standards and Schemes

View Medical Device related standards and schemes offered by LRQA.

Medical devices standards and schemes

Medical Device Directive (MDD)

CE marking to the Medical Device Directive, 93/42/EEC is important if you manufacture or distribute medical devices within the European Economic Area.

IVD Directive (IVDD)

The In Vitro Diagnostic (IVD) Medical Devices Directive introduced for the first time common regulatory requirements within the European Economic Area dealing specifically with the safety, quality and performance of in vitro diagnostic medical devices (IVDs). This brings them into line with other medical devices. In essence, the Directive aims to make sure that IVDs are safe for use and meets the performance levels specified by their manufacturer.

Medical Device Single Audit Program (MDSAP)

MDSAP allows medical device manufacturers to have a single audit of their Quality Management System (QMS) which satisfies the requirements of multiple regulatory jurisdictions: Australia, Brazil, Canada, Japan and the United States.