risk management and analysis

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    Risk Approach doesn't address External Issues (Auditor's Comment)

    Hello Everyone :) , If some of you could remember my inquiry I posted here before about: Auditor requests confidential information via Email , I am indeed so grateful for your help. The Audit was last Wednesday and it went really very systematic and informative ( I was a little bit afraid that...
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    Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management

    Health Canada issued this notice of intent back in April regarding "Strengthening the post-market surveillance and risk management of Medical Devices". As written in the notice, most of the proposed changes are written in the format "Provide the Minister with the authority to...". Does this...
  3. Marcelo Antunes

    Medical Device News FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices

    Office of Inspector General of the U.S. Department of Health & Human Services (HHS) - The Food and Drug Administration's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices Full Report - https://oig.hhs.gov/oas/reports/region18/181630530.pdf
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    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...
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    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...
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    Electronic Instructions for use (eIFU)

    Hi all I'm going to perform a risk analysis of our eIFU according to REGULATION (EU) No 207/2012.Has anyone performed this, and how did you do it? I'm struggling a bit.
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    Evidence of precautions (clinical evaluation report, risk management report)

    I added precaution to IFU. Evidence of precautions is in the literature. How should this literature be described in the clinical evaluation report?
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    Risk / benefit Analysis in Risk Management Report

    Risk / benefit analysis for each risk. Is there an example?
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    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.
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    Electronic Signature - Certificate

    Dears, Thinking about the need for a digital signature certificate...do you think it´s necessary for which situations? I mean, If I have a good audit trail and controls like: - confirmation - user and password - before approve/sign a document - the signature responsible, hour and date...
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    Manufacturing site relocation of pre amendment Class II medical device

    Good Day - Trying to determine what a risk analysis would look like for moving our manufacturing process of a pre amendment class II medical device. Thanks in advance for inputs.
  12. Marcelo Antunes

    Medical Device News FDA news - 05-09-18 - Draft - Uncertainty in Benefit-Risk Determinations

    FDA - Draft Guidance on Considering Uncertainty in Making Benefit-Risk Determinations to Support Certain Premarket Decisions for Medical Devices https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM619220.pdf
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    How to Document Risk Effects on Design Change(s)

    Hi everybody! I was wondering if someone can help me and explain how to document change happen on initial device requirement after risk assessment over requirements?
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    IATF 16949 Clause 6.1.2.1 - Lessons Learned and Risk Analysis

    The clause 6.1.2.1: The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework. This mean that we should include the lessons learned from product recalls, also lessons...
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    Essential performance, accompanying documents....confused

    Hello, I feel I have a reasonable understanding of the concept of essential performance but in Annex A clause 4.3 of IEC60601-1 Ed 3.1, there is the following sentence: "When considering the RISK associated with a level of degraded performance, which might include full loss, the analysis...
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    Closing Out Negative Issues in Context and Interested Parties

    Hello everybody At managing risks, I have been following this practice when identifying external issues (negatives) and in Interested parties the suppliers. Example: When ran the FODA, In external issues, I identified negative (risk) in external issues the Goverment policies. And when...
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    Risk analysis 6.1 and contingency plans 6.1.2.3, are they related?

    In IATF 16949 clause 6.1, which is the same as in ISO 9001, we need to conduct a risk analysis and then plan actions to mitigate such risks. Then the contingency plan clause 6.1.2.3, mentions the risks analysis and risk mitigation activity again. What is the difference between 6.1...
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    Risk-based Design

    We are a small medical device company and recently we had a management review meeting and our CEO mentioned that he heard about a new risk approach - "risk-based design". Basically, that risk assessment is done over the requirements of a medical device - you identify a risk, show mitigation for...
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    Qualitative or Quantitative? Risk method evaluation

    Hello everybody In the approach to manage risk under 9001 2015, I´m considering this. I use the equation Risk value = PxI Once I get the value, I have a table of values which correspond to a Type of risk, ranking form A to D. My sources to evaluate P and are just references, events in...
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    Risk Mitigation Through Outsourced Manufacturing

    Hello, Some regulatory schemes prescribe a fixed hierarchy of risk control categories that should be examined in the following order: 1. Inherent safety by design 2. Protective measures in the device or its manufacture 3. Information for safety, such as warnings, maintenance schedules...
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