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2018

  1. Marcelo Antunes

    Informational EU – MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers

    MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  2. 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...
  3. Marc

    As the earliest wind farms age - Dec 2018 Ars article

    Scroby Sands offshore wind farm, Caister, Great Yarmouth, Norfolk, England. FTFA: Money was the reason these turbines were upgraded rather than replaced. A single modern turbine can produce as much power as the entire original farm.
  4. Marc

    A Four Day Work Week - Reuters - Dec 2018

    Companies around the world have cut their work week down to just four days and found that it leads to higher productivity, more motivated staff and less burnout. Reuters highlights some of those companies:
  5. Marcelo Antunes

    Medical Device News ANVISA – Consulta Pública nº 586 de 20/12/2018 – Diretrizes de Garantia da Qualidade para Validação, Monitoramento e Controle de Rotina dos Processos

    ANVISA – Public Consultation No. 586 of 12/20/2018 – Proposal for Normative Ruling on the Quality Assurance Guidelines for Validation, Monitoring and Routine Control of Sterilization Processes and Automated Processes for Cleaning and Disinfection in Health Services. ANVISA – Consulta Pública nº...
  6. 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...
  7. Marcelo Antunes

    Medical Device News ANVISA – Consulta Pública nº 584 de 20/12/2018 – Enquadramento de dispositivo médico como de uso único ou reutilizável

    ANVISA – Public Consultation nº 584 of 12/20/2018 – Framework of medical device as single use or reusable ANVISA – Consulta Pública nº 584 de 20/12/2018 – Enquadramento de dispositivo médico como de uso único ou reutilizável Continue reading...
  8. Marcelo Antunes

    Medical Device News MedTech Europe Statement on the Implant Files

    MedTech Europe Statement on the Implant Files Continue reading...
  9. 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...
  10. Marcelo Antunes

    FDA News Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

    USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Alerta de segurança – USFDA adverte sobre os riscos de segurança de colares de dentição, pulseiras para aliviar a dor na dentição ou para fornecer estimulação sensorial...
  11. Marcelo Antunes

    FDA News USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management

    Interesting findings and recommendations – Medical Device User Fee Amendments IV Independent Assessment of Food and Drug Administration’s Device Review Process Management – Final Report and Recommendations Continue reading...
  12. Marcelo Antunes

    FDA News USFDA – Reclassification of Electroconvulsive Therapy Devices

    Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses Continue reading...
  13. Marcelo Antunes

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

    MDSAP Stakeholder Day Presentations – December 5, 2018 Continue reading...
  14. Marc

    Christmas - 2018

    Christmas is nearly here... Merry Christmas, Happy Holidays, and Happy New Year to everyone! These are some old files you might be interested in... Index of /Christmas - Right Click to download individual files.
  15. Ajit Basrur

    MDSAP Presentations - Dec 5, 2018 - Stakeholders

    The MDSAP Consortium has posted the Stakeholder Day presentations provided to manufacturers and trade organizations on December 5, 2018, at the Pan American Health Organization Headquarters in Washington, DC. See Medical Device Single Audit Program (MDSAP) - Stakeholders
  16. Marcelo Antunes

    Medical Device News New Zealand – Therapeutic Products Regulatory Scheme consultation

    Comments on both the Therapeutic Products Bill and the Therapeutic Products Regulatory Scheme: Consultation document. Continue reading...
  17. Marcelo Antunes

    FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available

    REPORT ON NON-DEVICE SOFTWARE FUNCTIONS: IMPACT TO HEALTH AND BEST PRACTICES – DECEMBER 2018 Continue reading...
  18. Marcelo Antunes

    FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission

    Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; AvailabilityFederal Register :: Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff...
  19. Marcelo Antunes

    FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures

    Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Continue reading...
  20. Marcelo Antunes

    FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment

    Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Continue reading...
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