Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

risk management and analysis

  1. Ashok sunder

    Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk?

    Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk?
  2. D

    Doing both a top-down and a bottom-up risk assessment - How to combine

    Hello, If conducting both a top-down (e.g. FTA, PHA) and a bottom-up (e.g. FMEA) risk assessment for a design of a medical product how does one combine the results? Is their a normal way? I assume they should be done independently from each other but one concern is in conducting both...
  3. Marcelo Antunes

    Informational Análise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto risco (Portuguese only)

    Análise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto risco. Conclusões:Considerando a amostra de indeferimentos de registro sanitário estudada, os achados sugerem uma heterogeneidade tanto na qualidade quanto no formato dos dados fornecidos em avaliações...
  4. 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...
  5. C

    Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach

    Hi everyone, We have a Class IIa Medical Device that it is a wipe to apply on the skin. We have a few risks of use error with this product because the user interface is very simple and easy to understand... Based on the first risk analysis of the product, do you think that I can avoid...
  6. 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...
  7. 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??
  8. D

    IEC 60601-1 - Essential performance doesn't make sense

    Hello, When determining essential performance, the guidance in 60601-1 is to assume with 100% certainty that a device's performance has degraded beyond some limit (determined by the manufacturer) which results in unacceptable risk. In reality if this was to happen, since a patient is getting...
  9. T

    IEC 60601-1 - Risk assessment to determine the liquid - 11.6.3

    IEC 60601-1 - Risk assessment for liquid determination - 11.6.3 how to deal with risk management
  10. P

    Looking for Risk Assessment Template - Not necessarily Asset based

    Hi, Most of the Risk assessment templates that I have seen are all Asset based. You start with asset register, and look for risks and mitigation plans. I guess that was a standard approach in ISO 27001:2005. There are a couple of templates on the internet, however they are again asset based...
  11. P

    What is the exact difference between Risk and Opportunity in context of ISO 27001?

    Hi All, ISO 27001:2013 defines planning for Risks and Opportunities. It's bit confusing to understand Opportunity as a positive risk. Unfortunately there's no documented definition of Opportunity available in ISO 27000 vocabulary. Can someone help me understand the exact difference between...
  12. S

    Can anybody share a sample risk assessment prepared based on ISO 17025:2017?

    Hi All Can anybody share a sample risk assessment prepared based on ISO 17025:2017 accredited laboratories??
  13. 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...
  14. R

    Customer supplied material - risk and policy advice needed

    My employer has a couple of legacy customers who supply material which we laser cut, form, or weld, and they then buy the finished product. If everything goes well, and there is no scrap, this work is profitable. When scrap does occur, the cost of replacing material, or crediting the customer...
  15. J

    Software for Techfiles and Risk management

    Hello Everyone, Just wondering if anyone has good suggestions for software solution for risk management? Also, if that same software can be used for updating tech files? Thank you!
  16. K

    Risk Analysis Updates due to complaints

    Currently I am having issue trying to get everyone (Quality, Regulatory, Engineering) on the same page regarding the risk analysis. We basically use a FMEA approach for our risk analysis then list mitigation, risk acceptability, risk benefit analysis, you get the point. We have it set up so...
  17. T

    DFMEA/PFMEA and SCCAF alignment

    Hello everybody, I work as a quality engineer for the past year and I am very much interested in DFMEA/PFMEA and SCCAF The engineers where I work are unable to tell me the following: 1 ) should DFMEA and PFMEA be aligned in terms of SC and CC (Significant and Critical Characteristics). When I...
  18. Marcelo Antunes

    Informational ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019

    Um vídeo sobre a reunião em São Paulo do ISO TC 210 IEC SC 62A JWG 1 Aplicação da Gerenciamento de Riscos a Dispositivos Médicos com comentários dos participantes. A video about the São Paulo meeting of ISO TC 210 IEC SC 62A JWG 1 Application of Risk Manegement to Medical Devices with comments...
  19. Marcelo Antunes

    Medical Device News ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019

    Um vídeo sobre a reunião em São Paulo do ISO TC 210 IEC SC 62A JWG 1 Aplicação da Gerenciamento de Riscos a Dispositivos Médicos com comentários dos participantes. A video about the São Paulo meeting of ISO TC 210 IEC SC 62A JWG 1 Application of Risk Manegement to Medical Devices with comments...
  20. 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...
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