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  • PD CEN ISO/TR 14969 2005Medical devices. Quality

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  • Procedure for Adverse Event Investigation and Reporting

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  • ISO 13485 2016 Lead Auditor TrainingSAE Training

    ISO 13485 2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO

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  • BS EN ISO 13485 2003Medical devices. Quality

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    Aduhelm (aducanumab-avwa) is a prescription medicine used to treat Alzheimer’s disease. It is the first novel therapy approved for Alzheimer’s disease since 2003. As of June 11 2021, TheSocialMedwork can help you access Aduhelm if you are outside of the United States. Make an enquiry below. ___________________ Please note that the FDA's decision to approve Aduhelm has been criticised