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imdrf (international medical devices regulators forum)

  1. Marcelo Antunes

    Informational IMDRF – Proposed update to Clinical Evaluation documents

    Proposed update to Clinical Evaluation documents Posted at Marcelo's website... You may comment and discuss in this discussion thread.
  2. Marcelo Antunes

    Informational CDRH Proposes New IMDRF Work Item on Standards

    CDRH Proposes New IMDRF Work Item on Standards Posted at Marcelo's website... You may comment and discuss in this discussion thread.
  3. 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...
  4. S

    Regulatory Certification Exam (RAC) - Global Scope

    Hi everyone For those who have taken the Global Scope exam, what study tips can you offer? Is it sufficient to read the Fundamentals textbook? Or should we also go over the ICH guidelines? Thank you.
  5. Marcelo Antunes

    Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices

    IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways | RAPS
  6. FoGia

    IMDRF opened a Consultation on Annex E & F and the link to ISO 14971

    Hello, IMDRF opened a consultation regarding annex E & F on their draft guidance related to health effects. According to their guidance, adverse events ought to be classified following their clinical signs, symptoms and conditions on one hand and following their health impact on the other...
  7. L

    Classification of Medical vs Wellness Devices

    Hello there, Thank you for all of the guidance you folks have provided on the forums so far. It has been very informative. I have been trying to get a handle on classification of digital health devices in Canada. I have not been able to locate a formal guidance document on the difference...
  8. Sidney Vianna

    Optimizing Standards for Regulatory Use - International Medical Dev. Regulators Forum

    From International Medical Device Regulators Seek Input on Proposed Guidance for Optimizing Standards for Regulatory Use The International Medical Device Regulators Forum (IMDRF), a global coalition of medical device regulators working to harmonize regulatory approaches globally, is seeking...
  9. T

    MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41

    We have written our clinical evaluation work instructions to comply with MEDDEV 2.7/1 r4. I'm now trying to figure out how IMDRF/SaMD WG/N41 fits in to all of this. While the verbiage is different, it appears to refer to the same concepts. What I'm really struggling with is whether I must...
  10. H

    GHTF and IMDRF - Alternative for the STED format

    Hello I am CE marking a low risk self declared IVD and was advised to follow the STED format for the technical file outlined by the GHTF. However, this body has now been replaced by the IMDRF and am trying to find an alternative for the STED format or can I use the already existing one? As...
  11. K

    IEC 62304 - Compliance steps

    Hi, My company is ISO:13485 certified and ISO:14971 complaint (almost). I was wondering whether there is a guideline which identifies the modifications required on the QS in order to adapt to IEC 62304 as well? As far as I have understood, we are not that far. Thanks!
  12. SteveK

    NB-MED, NBOG, IMDRF and MEDDEV hierarchy

    There is NB-MED/2.5.2/Rec2 ?Reporting of design changes and changes of the quality system? and now we have NBOG BPG 2014-3 ?Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System?. The latter document references the former. These may be...
  13. Marcelo Antunes

    IMDRF document - Application of QMS to SaMD

    Not sure if everyone is aware, but the IMDRF SaMD group (which I?m also a member, representing Brazilian Industry) is creating a new document titled: Software as a Medical Device (SaMD): Applicability of Existing Quality Management System Requirements as a Risk Control Measure The objective...
  14. B

    Are the GHTF guidance documents still relevant?

    Given that the GHTF ceased to be in 2012 are the guidance documents they produced still relevant? I use them all the time but have just started to question my judgement. What do you guy's think?
  15. W

    IEC 62304 vs. IMDRF SaMD Guideline Risk Class

    Looking for some ideas and writing off some frustration. One of the main issues during the implementation and working with the IEC 62304 is the risk classification of the medical device software. I'm speaking here from a standalone software view point, but integrated software will probably have...
  16. L

    Find Local Authorized Representative (LAR) for medical device

    Hello everyone:bigwave: , I am Luna - from Perfect Medical Industry Co.,Ltd in Vietnam. We are manufacture of medical device. I want to export two products such as hemodialysis blood line and A.V.Fistula into MY market. Both devices are Class-IIa as per MDD 93/42/EEC and Class-C as per IMDRF...
  17. Marc

    Determination of Sample Sizes when Auditing

    An oldie but goodie... How do you determine sample size when auditing records? How do you determine sample size when auditing a process across multiple production lines? How do you determine sample size when asking employees how their company quality policy? What statistically valid...
  18. M

    ISO 13485 and Class 1 Medical Device - FDA thinking

    Some devices classified by FDA as Class 1, especially those that are exempt from general controls, are not necessarily considered to be devices under various global regulations. For example, feminine menstrual pads are Class 1 in the US, but they are not considered as medical devices in Canada...
  19. P

    IMDRF (International Medical Devices Regulators Forum)guidance on standalone software

    The IMDRF (the organization that replaces GHTF) have released a draft document on Standalone Medical Device Software, with key definitions. It is likely this will be the starting point for how this type of software is regulated in the future. Comments are invited, with a deadline of August 30...
  20. A

    IMDRF Working With ICH on Harmonized Electronic Submission System for Drugs, Devices

    Regulators, Industry Discuss Potential Impact of IMDRF An Update on the IMDRF and Sunsetting of the GHTF
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