Relevant assessment Standards, Schemes & Directives within this sector:
ISO 13485:2003 is an international standard that defines quality management system requirements for manufacturers of medical devices.
ISO 14001 is the international specification for an environmental quality management system (EMS).
Certification to the internationally recognised quality management system standard provides clear demonstration of your organisation's comittment to quality
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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