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View Full Version : ISO 14971 - Medical Device Risk and Hazard Control

  1. Applicability of Risk Management for Medical Devices - ISO 14971:2000
  2. CE-marked devices require EN ISO 14971 risk management
  3. ISO 14971 replaces EN 1441 - Risk Analysis and Technical Files/Device Master Files
  4. Risk Management ISO 14971 - Samples and How to Go about it
  5. ISO14971:2001 - Risk Management for Medical Devices - Help need copy
  6. ISO 14971 - Risk Analysis - Seeking guide and / or summary
  7. ISO 13485 & ISO 14971 - Requirements for risk management
  8. Do we require compliance to ISO 14971 (Risk Management)?
  9. ISO 14971 and 13485 - Is ISO14971 just a supplement to ISO13485?
  10. How do you calculate Overall Residual Risk - Requirement of 14971 Risk Management
  11. FMEA "Types" - ISO 14971 (Medical Devices - Application of Risk Management)
  12. post production Information as per ISO14971
  13. ISO13485 from a risk analysis point of view using 14971 as a guide
  14. ISO 14971 Risk Analysis - Effects of component failure on the patient
  15. Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the risk assessment
  16. Application of Risk Management - ISO 14971:2007(E) Medical Devices
  17. When should the medical device industry show compliance to EN ISO 14971(2007)
  18. Medical Device Software Risk Management and ISO 14971:2007
  19. UL First to Offer ISO 14971 Registration Service
  20. Looking for a good ISO 14971 checklist
  21. Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971.
  22. Risk Management Software suggestions?
  23. ISO 14971 - Product Risk Analysis and Reviews - New requirements?
  24. Life Cycle - ISO 14971:2007 meets ISO 14630:08
  25. Overall Residual Risk Procedure based on the 2007 version of ISO 14971
  26. KPIs (Key Performance Indicators) and Risk Management Process (ISO14971:2007)
  27. Defining Criteria for Risk Acceptability - ISO 14971 Clause 3.2
  28. Risk Management Plan for a Mature Product - ISO 14971
  29. ISO 14971:2003 vs. 14971:2007 - Major differences
  30. Risk Assessment according to ISO 14971 - Medical Device Software
  31. What is the necessary implementation date for ISO 14971:2007
  32. ISO 14971: Perceived or alleged risk?
  33. Risk Management Plan for Medical Device - ISO 14971
  34. How to make risk analysis for design changes to existing devices
  35. ISO 14971 DFU IFU Warning Adding Accessory
  36. Best Risk Analysis Approach (ISO 14971) - Class IIa Medical Devices
  37. ISO 14971: 2007 Risk Management File - Separate file required for each product?
  38. Should we rate according to the prob. a risk will occur or that risk causes hazards?
  39. What does the revision letter stand for in ISO 14971:2007(E)
  40. Does ISO 14971:2007 (E) apply to software?
  41. Medical Device FMEA vs. ISO 14971 to create our Hazard Analysis
  42. ISO 14971 Risk Management training courses in Montreal or Ottawa
  43. ISO 14971 Risk Management questions and comments
  44. Risk Analysis of Software - ISO 14971:2007
  45. ISO 14971:2007 Application of Risk Management to Medical Devices
  46. ISO14971 - Determination of possible hazards (SU, UU, PC)
  47. ISO 14971 for Contract Manufacturers - Extensive risk management
  48. ISO 14971 Risk Management Qualification of Personnel
  49. Need risk acceptance policy/criteria
  50. Biofeedback Risk Management
  51. BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007
  52. 10993-1:2009 what are the changes? Is the risk management according to 14971?
  53. Developing the Risk Managment Plan - Risk Management Policy and Objectives
  54. The US's FDA and other Medical Device Related Forums
  55. ISO 14971 becomes mandatory in Brazil - ANVISA Normative Instruction 13/2009
  56. ISO 14971:2007 Risk Management - Class I A Sterile Medical Device
  57. Seeking thoughts on using BOTH FTA (Fault Tree Analysis) and FMEA
  58. Interesting article - Analysis of Risk: Are Current Methods Theoretically Sound?