Essentials of European Medical Device Regulatory Affairs

More Information Sources

More Specific Standards • Sterilization • Biological evaluation of medical devices • Medical Electrical safety • Packaging Materials for devices to be sterilized General Standards

• Quality systems • Risk Management • Clinical Investigation of MDs for human subjects Good Clinical Practice • Graphic Symbols • Information supplied by the manufacturer Product Specific Standards • e.g. For Respiratory equipment, Joint replacement implants, Clinical thermometers, Oxygen monitors

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Module 4

• Classification of devices

• Classification rules

• Reclassification of devices

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