W
WBubel - 2010
ISO 14971:2007(E) Medical devices — Application of risk, March 1, 2007
I have just reviewed the new ISO 14971:2007 there seems to be major changes in the area of Risk Management. Specially in the Annex's
Annex A (informative) Rationale for requirements
Annex B (informative) Overview of the risk management process for medical devices.
Annex C (informative) Questions that can be used to identify medical device characteristics thatcould impact on safety.
Annex D (informative) Risk concepts applied to medical devices.
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations.
Annex F (informative) Risk management plan.
Annex G (informative) Information on risk management techniques.
Annex H (informative) Guidance on risk management for in vitro diagnostic medical devices.
Annex I (informative) Guidance on risk analysis process for biological hazards.
Annex J (informative) Information for safety and information about residual risk.
Has anyone else had a chance to look at it and what are your opinions as to its impact on existing risk management plans.
I have just reviewed the new ISO 14971:2007 there seems to be major changes in the area of Risk Management. Specially in the Annex's
Annex A (informative) Rationale for requirements
Annex B (informative) Overview of the risk management process for medical devices.
Annex C (informative) Questions that can be used to identify medical device characteristics thatcould impact on safety.
Annex D (informative) Risk concepts applied to medical devices.
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations.
Annex F (informative) Risk management plan.
Annex G (informative) Information on risk management techniques.
Annex H (informative) Guidance on risk management for in vitro diagnostic medical devices.
Annex I (informative) Guidance on risk analysis process for biological hazards.
Annex J (informative) Information for safety and information about residual risk.
Has anyone else had a chance to look at it and what are your opinions as to its impact on existing risk management plans.