Life Cycle of a Medical Device Transfer to Manufacturing一个医疗设备转移到制造生命周期.pptVIP

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2018-06-30 发布于浙江
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Life Cycle of a Medical Device Transfer to Manufacturing一个医疗设备转移到制造生命周期.ppt

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Life Cycle of a Medical Device Transfer to Manufacturing一个医疗设备转移到制造生命周期

* * * * * * * * * * * * * * * * 7.3 Design and Development * A documented procedure is required. More records are required Design inputs must include safety and performance requirements Design inputs must be approved Records of design outputs are required Independent person required at design review Clinical evaluation as part of design validation 7.4 Purchasing * Documented procedure required FDA requirement: Where appropriate, purchasing documents will include an agreement that the supplier will notify the manufacturer of any changes to the product or service so that the manufacturer may assess the impact of the change on the finished device Unauthorized changes can have a significant impact and result in recalls by the manufacturer Evaluation of suppliers is typically risk-based 7.5 Production and Service Provision * The availability of documented procedures, requirements, work instructions, and reference materials and reference measurement procedures as necessary The implementation of defined operations for labelling and packaging Record that shows manufacturing history including quantity. Record shall be reviewed and approved. 7.5 Production and Service Provision * Cleanliness of product and contamination control A documented procedure is required Intended for devices sold sterile or Devices to be sterilized by the end user Installation and servicing procedures and controls Specific requirements for sterile and implantable devices 7.5 Production and Service Provision * Procedure for the validation of computer software Records of these activities Procedure for ID and traceability—more stringent controls or implantable devices Procedure to distinguished returned product from conforming product Status of product—must be known at all times throughout the product realization process Procedure for the preservation of product conformity—handling, storage 7.5 Production and Service Provision * Procedure for devices with a limited shelf lif