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Transmissible Spongiform Encephalopathies (TSE): TGA …

    https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/guidelines-sterility-testing-therapeutic-goods/transmissible-spongiform-encephalopathies-tse-tga-approach-minimising-risk-exposure
    Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure. How the TGA assesses the safety of materials derived from human and …

Medical Device Viral Inactivation | Charles River

    https://www.criver.com/industry/medical-device/medical-device-viral-inactivation
    For over 20 years, we’ve conducted viral and TSE clearance studies for medical devices leading clients through the risk assessment, planning, and execution of such viral …

FDA Updates TSE and Mad Cow Disease Guidance for …

    https://www.lifescienceslegalupdate.com/2014/01/articles/regulatory-developments/fda-updates-tse-and-mad-cow-disease-guidance-for-medical-devices/
    To address the risks of TSEs, FDA recently released a draft guidance entitled “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro …

Guidelines on Medical devices - BSE TSE - Team NB

    https://www.team-nb.org/wp-content/uploads/2015/05/documents2012andolders/2_11_1%20_rev1_bsetse_april2005.pdf
    ACCOUNT THE COMMISSION DIRECTIVE 2003/32/EC FOR MEDICAL DEVICES UTILISING TISSUES OR DERIVATIVES ORIGINATING FROM ANIMALS FOR WHICH …

Contacts - Public Health

    https://health.ec.europa.eu/medical-devices-sector/new-regulations/contacts_en
    European Association of Notified bodies for Medical devices (Team-NB) Notified body operations group (NBOG) Standards European Committee for standardization (CEN) and …

What is a BSE/TSE Certificate and Why …

    https://goldbio.com/articles/article/what-is-a-bsetse-certificate-and-why-should-you-care
    I’ll discuss what it means to be TSE (Transmissible Spongiform Encephalopathy) compliant and why TSE certificates are so important. TSE compliance certificates are a type of CEP (Certificate of …

Bovine Spongiform Encephalopathy | FDA

    https://www.fda.gov/animal-veterinary/compliance-enforcement/bovine-spongiform-encephalopathy
    Bovine Spongiform Encephalopathy (BSE) belongs to the unusual group of progressively degenerative neurological diseases known as transmissible spongiform encephalopathies …

TSE MEDICAL - production of medical equipment for …

    https://www.tse-medical.cz/
    TSE MEDICAL - production of medical equipment for neonatology - TSE MEDICAL PHOTOTHERAPY SMART DESIGN INCUBATORS PHOTOTHERAPY INFANT …

Medical devices utilizing animal tissue in the industry | BSI

    https://www.bsigroup.com/en-GB/medical-devices/technologies/animal-tissue/
    BSI is one of a few Notified Bodies designated to certify devices manufactured utilising materials of animal origin including those derived from Transmissible Spongiform …

ISO - ISO 22442-1:2015 - Medical devices utilizing …

    https://www.iso.org/standard/68553.html
    ISO 22442-1:2015 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have …



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