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Topics include the characteristics and applications of materials used for medical implants, precision machining, polyurethane in biomedical applications, customized cranio-facial implants design and manufacture, technological advances for polymers in active implantable medical devices, integrated telemedicine systems, application of the finite method in spinal implant design and manufacture, and more.
The relevant directives are 90/385/EEC Active Implantable Medical Devices and 93/42/EEC Medical Devices.
Scope of the proposed new regulation E-labelling will only be for devices exclusively used by professional users (home use devices will not be covered) and applicable to Medical Devices Directive 93/42/EEC (as amended by 2007/47/EC) and Active Implantable Medical Devices Directive 90/385/EEC.
Part 2 Challenges of implantable systems: Biocompatibility of implantable systems - Sterilisation considerations for implantable sensor systems - Protection of data confidentiality and patient privacy in medical sensor networks - Developing active implantable medical devices in a regulated environment.
The relevant directives are Active Implantable Medical Devices, 93/42/EEC Medical devices and 98/79/EC In Vitro Diagnostic Medical Devices.
Within the European Economic Area ("EEA"), medical devices are regulated by three European directives ("the Directives"): * The Medical Devices Directive ("MDD") * The Active Implantable Medical Devices Directive ("AIMDD") * The In Vitro Diagnostic Devices Directive ("IVDD") The Directives were established to provide a harmonised regulatory procedure for all medical devices within the EEA.
FDA QSR and GMP requirements, as well as European medical device and active implantable medical device directives, requires that medical device companies provide a high degree of assurance that their products, and the processes used to manufacture medical products, consistently meet specifies requirements and user needs* Proven Process uses a wide range of verification and validation methods to help you meet that challenge including Product and Process Validation Planning, Product and Process Requirements Analysis, Specification and Verification, Software Verification and Validation, Fault Tree Modeling, Failure Modes and Defects Analysis, Process Design Validation, Vendor Qualification, Defect Tracking, Configuration Management, and Risk Management.
This successful audit demonstrates Cyberonics' compliance with the ISO 13485:1996 Quality System Standards for Medical Devices and the Active Implantable Medical Device Directive.