risk management and analysis

  1. C

    Resource allocation problems in Software DFMEA

    Dear all, While working on Software FMEAs we realized that each piece of software made certain use of common resources: Execution time, RAM, ROM, etc... If a failure of a characteristic of that piece of software is defined as: Execution time is too long Its mother function will only fail in a...
  2. E

    Root Cause CAPAs from internal audit

    We recently upgraded our QMS to ISO 13485:2016. Prior to that we had an internal audit performed by a consultant. We have 5 minor non conformances relating specifically to the new 2016 standard. In our root cause analysis I would like to present the idea that we knew there was a risk in moving...
  3. B

    ISO 9001:2015 6.1.1 b - Enhance desirable effects - No opportunities were addressed

    Our CB Auditor issued a Minor Nonconformance stating "Risks identified show enhancement of desirable effects, and no opportunities were addressed." This was a recert audit. He is recommending us for recert, but the NC has to be addressed. Regarding opportunities, we just need to do a better...
  4. T

    Risk Management Report as per MDR Requirements

    Hi All, Anyone have template of risk management report as per MDR requirements please share for community reuse. Thanks in advance.
  5. MrTetris

    Informational Risk Register - Same hazardous situation, different severity of harms

    Hello, I tried to read the faq and first two pages, but I could not find an answer to a probably basic question about the Risk Register. My company is a manufacturer of imaging SaMD, used to prepare surgical plans. One of the hazards considered in our Risk Register is the possibility for the...
  6. P

    Understanding FDA draft "Management of Cybersecurity in Medical Devices"

    Hi everyone, I'm trying to get an idea of what this new FDA draft - "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Document issued on October 18, 2018) implies for our company and our new designs. The way I see it is that medical devices with complex User...
  7. R

    IEC 60601-2-57 Risk Group 2 OHD

    We're dealing with a LED device classified as Group Risk 2 according to the blue light emission limit. That requires OHD (ocular hazard distance) to be provided in the instructions for use. Should it be calculated according to the radiance and irradiance measurements we got for the blue light or...
  8. S

    Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness

    I was recently given a noncompliance against ISO 13485: 2016, clause 6.2 Human resources because of the NOTE " The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided." I am a contract converter...
  9. S

    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...
  10. M

    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...
  11. 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
  12. 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...
  13. 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...
  14. N

    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.
  15. Q

    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?
  16. Q

    Risk / benefit Analysis in Risk Management Report

    Risk / benefit analysis for each risk. Is there an example?
  17. 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.
  18. M

    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...
  19. B

    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.
  20. 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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