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View Medical Device related standards and schemes offered by LRQA.
CE marking to the Medical Device Directive, 93/42/EEC is important if you manufacture or distribute medical devices within the European Economic Area.
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.
LRQA provides accredited certification and training services to ISO 13485, the quality management system requirement for manufacturers of medical devices.
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.
The ISO 15378 standard is applicable to organisations which need to demonstrate the ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements.
LRQA can provide assessment and certification services to PS 9000, which was the standard developed for manufacturers of packaging material for medicinal products with reference to the Good Manufacturing Practice (GMP).