medical device news

  1. Marcelo Antunes

    Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments

    Nonbinding Feedback After Certain FDA Inspections of Device Establishments Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  2. Marcelo Antunes

    Informational The USFDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019

    Topics to be discussed: breast implant associated anaplastic large cell lymphoma (BIA-ALCL); systemic symptoms reported in patients receiving breast implants; the use of registries for breast implant surveillance; magnetic resonance imaging (MRI) screening for silent rupture of silicone gel...
  3. Marcelo Antunes

    Medical Device News USFSA – 2019 Meeting Materials of the Obstetrics and Gynecology Devices Panel

    Interesting reads regarding a surgical mesh (in particular in view of the recent discussion on the Bleeding Edge and Implant files): 2019 Meeting Materials of the Obstetrics and Gynecology Devices Panel Continue reading at the source... You may also comment/reply in this discussion thread.
  4. Marcelo Antunes

    Medical Device News Manual On Borderline And Classification In The Community Regulatory Framework For Medical Devices

    New version, Version 1.21 (01-2019) – Manual On Borderline And Classification In The Community Regulatory Framework For Medical Devices Continue reading...
  5. Marcelo Antunes

    Medical Device News EU – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

    In several EU languages – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics Continue reading...
  6. Marcelo Antunes

    Medical Device News EU interesting developments – embracing MDSAP and UDI alignment

    Medical Devices: The EU will take steps to make use of single audit reports (an initiative of the International Medical Device Regulators Forum – IMDRF) in a manner that is compatible with EU legislative requirements. The EU and US will cooperate to ensure alignment of electronic database...
  7. Marcelo Antunes

    Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices

    Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Continue reading...
  8. Marcelo Antunes

    Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018

    MDR and IVDR implementing measures rolling plan – December 2018 Continue reading...
  9. Marcelo Antunes

    Medical Device News EC – Commission reply to a Petition “For a Compensation Fund for PIP Breast Implants and CE” from the website change.org

    Commission reply to a Petition “For a Compensation Fund for PIP Breast Implants and CE” from the website change.org Continue reading...
  10. Marcelo Antunes

    Medical Device News Disponibilizados textos das CPs 584, 585 e 585 da ANVISA

    Texts of ANVISA CPs 584, 585 and 585 are available. Comments and suggestion until March 9th. Disponibilizados textos das CPs 584, 585 e 585 da ANVISA. Comentários e sugestões até 9 de Março. Consulta Pública n° 584, de 20 de dezembro de 2018 – Proposta de Resolução que Dispõe sobre o...
  11. Marcelo Antunes

    Medical Device News DHS – Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients

    A new report by the US DHS – Health Industry Cybersecurity Practices:Managing Threats and Protecting Patients Continue reading...
  12. Marcelo Antunes

    Medical Device News TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

    TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy Continue reading...
  13. Marcelo Antunes

    Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

    TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Continue reading...
  14. Marcelo Antunes

    Medical Device News MHRA releases response to consultation on EU exit no-deal legislative proposals

    MHRA response to EU exit no-deal legislative proposals consultation Continue reading...
  15. Marcelo Antunes

    Medical Device News ANVISA – Consulta Pública nº 585 de 20/12/2018 – Boas Práticas para o Processamento de Produtos utilizados na assistência à saúde

    ANVISA – Public Consultation No. 585 of 12/20/2018 – Proposal of Resolution of the Collegiate Board of Directors – RDC, which provides for the requirements of Good Practices for the Processing of Products used in health care, and provides other measures. ANVISA – Consulta Pública nº 585 de...
  16. Marcelo Antunes

    Medical Device News MedTech Europe Statement on the Implant Files

    MedTech Europe Statement on the Implant Files Continue reading...
  17. Marcelo Antunes

    Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation

    Interesting findings – “results of the computer-simulated VICTRE trial are consistent with the comparative trial using human subjects and human image interpreters. While further research is needed to assess the generalizability of the findings, the work reported in this article provides evidence...
  18. Marcelo Antunes

    Medical Device News MDSAP Stakeholder Day – December 5, 2018 presentations

    MDSAP Stakeholder Day Presentations – December 5, 2018 Continue reading...
  19. Marcelo Antunes

    Medical Device News EU MDR – Information on stages in designation process from Team-NB

    Survey regarding where members of Team-nB are in the MDR designation process – Team-NB is publishing a survey on the MDR designation process present stages in which Team-NB notified bodies member are. Pesquisa sobre onde os membros do Team-nB estão no processo de designação para o MDR – Team-NB...
  20. Marcelo Antunes

    Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application”

    Here: NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” Continue reading...
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