Please find below a list of Healthcare & Medical Standards, Schemes and Directives for which LRQA can provide assessment, certification, verification and training services.
ISO 13485:2003 is an international standard that defines quality management system requirements for manufacturers of medical devices.
The quality management system standard
The In Vitro Diagnostic (IVD) Medical Devices Directive is relevant to you if you design, manufacture or distribute IVD medical devices within the European Economic Area.
The directive covers all products which claim to have a medical purpose and which are used in and on the human body, from heart valves to scalpels, excluding in vitro diagnostics, which are covered in a separate directive.
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