iso 14971 - medical device risk management

  1. B

    Grouping of Products for Risk Analysis

    Hello, I'm wondering if the following approach would be legit and in compliance with ISO 14971: 1. Group different products based on common characteristics. 2. Conduct a risk analysis to identify risks that overlap / are the same for each product of the product group (see 1.). 3. Define...
  2. Marcelo Antunes

    Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão

    ISO TC 210 JWG 1 met last week in Stockholm to discuss the last steps of the revision of ISO 14971 and ISO 24971. The group finalized the discussion on the comments of ISO TR 24971 (with only a couple of comments awaiting discussion in the next weeks) and it is expected to circulate ISO TR 24971...
  3. R

    The difference b/w FMEA & Risk analysis as per iso 14971

    Hi Can somebody help in understanding the difference b/w FMEA & Risk analysis as per iso 14971??
  4. D

    Risk management according to ISO 14971 - When to document risk controls?

    Hello, When conducting risk management according to 14971 should you document risk controls that are already part of the "prototype" design. For example, a mains powered medical device might be designed with a power cord permanently attached to the device, rather than a detachable power cord...
  5. S

    The Severity of a Medical Device Hazard - Risk Analysis Clarification

    I am working on risk analysis. I need clarification regarding the severity of a hazard. Do we need to assign severity only considering that patient health is not affected....? An example case is: App crash. Although its not going to affect patient. From a company perspective, app crash is...
  6. Q

    Information for safety EN ISO 14971:2012 - Customer Risk Reduction

    Hi, According to EN ISO 14971:2012, information for safety can no longer be used to reduce risk. In that case, how do you reduce the risk of the customer using the device in the wrong environment (for example, using an MR Unsafe device in an MRI room)? For hardware in particular, I don't...
  7. Marcelo Antunes

    Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management

    Reunião do ISO TC 210 JWG 1 em São Paulo – Continuação da revisão da ISO 14971 e ISO TR 24971 – Gerenciamento de risco de dispositivos médicos ISO TC 210 JWG 1 is meeting in São Paulo this week to continue the revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Continue...
  8. A

    Our auditor requires us to attend a training on EN ISO 14971:2012

    Hi All, Our auditor requires us to attend a training on EN ISO 14971:2012 so that we could prepare the risk management documents accordingly. It seems that unless we attend the training, they would be happy with the risk management document. Currently we hold a document complying to ISO...
  9. S

    In a risk analysis, how can we tie mobile app security breach to ISO 14971?

    Hi everyone, In a risk analysis, how can we tie security breach (e.g. losing confidentiality of patient information) to ISO 14971? What is the severity level of harm for loss of confidentiality of information in a mobile app? I would think we should do that exploitability analysis first as per...
  10. 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.
  11. P

    Global medical device human factors/usability requirement

    Dear All, Just want to check with your experience regarding medical device usability. Besides US and EU, is there any country that specifically requires usability/human factors/IEC 62366, besides the result of ISO 13485:2016 or IEC 60601-1 (ed 3 or 3.1+) or (ISO 14971:2018+) Many thanks.
  12. 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...
  13. M

    Updates to EN 62366 & ISO 14971?

    Hi Everyone! I recently got an email notifying me of some upcoming changes/edits to the EN 62366 and ISO 14971 standards: EN 62366-1:2015 The email said there is a corrigendum (EN 62366-1:2015/AC:2018), but I've been unable to find any further information. Closest thing I could find is a 2016...
  14. D

    IEC 60601-1 and ISO 14971 Assessment

    We have submitted our product for 60601 certification and all EMC / Safety Markings have come back with passing results. However the test lab is requiring all the risk documentation before they will provide the certification report. Is this common? For instance, we have not finished our...
  15. Marcelo Antunes

    Example ISO 14971 policy and risk criteria

    I think I posted a version of this in the past, but here is a revised one. .
  16. P

    ISO 13485 and ISO 14971 - one mandates the other?

    Hi there (and happy 4th), An auditor wrote a NC for not following ISO 14971, while an audit for 13485, Here is the NC quote: • Risk Management Plan, OP-02, rev 5 does not contain a risk policy as required in ISO 14971:2007 clause 3.2 • Risk Management Plan, OP-02, rev 5 does not outline...
  17. D

    Rationale for Risk Acceptability Matrix - ISO 14971

    Hello, I have a question about defining Risk Acceptability Criteria (RAC) as required by 14971:2007. Specifically about the use of a matrix as per Annex D. Conceptually, when defining a RAC matrix should the acceptable area cover known unavoidable risks associated with the therapy. For...
  18. H

    Task analysis and ISO 14971

    Hi, I have a question about aligning risk analysis techniques such as task analysis with 14971. The cognitive task analysis for our purpose is to identify possible task failures and hazards so we can compare the differences between our generic drug/device combination product and the reference...
  19. M

    ISO 14971 and Stand-Alone Diagnostic Software

    Hi all -- I am really struggling with a risk analysis. We make a stand-alone software device which is used to view echocardiograms. If, for some reason, the software fails and part of the echocardiogram is missing, a physician could potentially plan treatment with missing information. Or if...
  20. dgrainger

    Benefit - What is the definition of Benefit in ISO 14971?

    Hi, I can't find a definition in the standard! Am I missing something?
Top Bottom