guidance documents

  1. Marcelo Antunes

    Informational US FDA draft guidance – Mouse Embryo Assay for Assisted Reproduction Technology Devices

    Mouse Embryo Assay for Assisted Reproduction Technology Devices Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  2. S

    Sterilization Site Move - Dec 2018 FDA Guidance Document

    Hello If we (the manufacturer) have to qualify a new sterilizer to sterilize our products, to whom the requirements listed in 9-13 in Section B of the FDA guidance titled "Manufacturing Site Change Supplements: Contens and Submission; dated Dec 2018" apply- contract sterilizer or the...
  3. Marcelo Antunes

    Informational MHRA Guidance – Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stent

    Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stents (DESs) to the MHRA Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  4. Marcelo Antunes

    Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

    Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  5. Marcelo Antunes

    Informational US FDA final guidance – Utilizing Animal Studies to Evaluate Organ Preservation Devices

    Utilizing Animal Studies to Evaluate Organ Preservation Devices Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  6. Marcelo Antunes

    Informational US FDA Medical X-ray Imaging Devices guidances

    Medical X-Ray Imaging Devices Conformance with IEC Standards Policy Clarification for Certain Fluoroscopic Equipment Requirements Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  7. L

    Medical Device Accessory - Health Canada guidance / definition on what an accessory is

    Hi, Does Canada have a guidance / definition on what an accessory is, similar to what the FDA has? Thanks in advance!
  8. Marcelo Antunes

    Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI

    MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  9. Marcelo Antunes

    Informational Some ISO guides for standardization work

    Guidance on the Systematic Review process in ISO Guidance on new work My ISO job – What delegates and experts need to know How to write standards – Tips for standards writers ISO Code of Conduct for the technical work Posted at Marcelo's Medicaldevice.expert website... You may comment and...
  10. Marcelo Antunes

    Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing

    Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  11. M

    EU MDR - UDI requirements and responsibility guidance

    Hi Everyone, Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility? Our company is the legal manufacturer and our distributors are the UDI partners. My question is if our company can delegate this responsibility to our...
  12. Marcelo Antunes

    Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions

    Technical Performance Assessment of Quantitative Imaging in Device Premarket Submission Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  13. Marcelo Antunes

    Informational USFDA draft guidance – Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol

    Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  14. S

    Informational New guidance documents about EUDAMED - April 2019

    The European Medical Devices Coordination Group (MDCG) published just a few days ago two guidance documents about EUDAMED: MDCG 2019-4 Timelines for registration of device data elements in EUDAMED MDCG 2019-5 Registration of legacy devices in EUDAMED FYI. Shimon
  15. Marcelo Antunes

    Informational MHRA – Virtual manufacturing of medical devices – Updated guidance

    Virtual manufacturing of medical devices. Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  16. Marcelo Antunes

    Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards

    USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  17. Marcelo Antunes

    Informational USFDA Final Guidance – Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)

    Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  18. Marcelo Antunes

    Informational Health Canada begins release of clinical data

    Based on this guidance – Public Release of Clinical Information: guidance document, see this website: Search for clinical information on drugs and medical devices - Canada.ca Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  19. Marcelo Antunes

    Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry

    A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  20. M

    Has anyone here assessed the latest Abbreviated 510(K) guidance document?

    A relatively new FDA abbreviated 510(K) guidance is published and I was wondering if anyone has assessed the gap analysis or created a summary report to state if the updated guidance is applicable to their QMS. Can you please share some ideas or scrubbed version? Thanks!
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