Guidelines and standards for medicines and medical devices
Medical devices are subject to strict general controls and procedural regulations. The development and use of standards is vital to ensuring the safety and efficacy of medical devices. Numerous regulatory agencies and standards organizations collaborate to establish the accepted standards for medical equipment. Standardâ€setting activities include the development of performance characteristics, characterization and testing methodologies, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labelling, or other technical or policy criteria. International Organization for Standardization, International Electro technical Commission, ASTM International. Guidelines include Inspection of the conduct of clinical evaluation of medical devices at health care providers, Medical Devices Vigilance system and Post Marketing Surveillance including monitoring and reporting of adverse incidents.
- Food and Drug Administration guidelines for medicines
- European medicine guidelines
- USA medical devices guidelines and standards
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