Hi Peter, The presentation is very informative and thanks for sharing. I wanted to understand, as a part of new 2019 version of the standard, should we have to specifically list out the reasonably foreseeable misuses about the product? If yes, where should it be? Is it as a part of intended use & indications of use of the product OR in the Risk management Review file? Please let us know.
I would say that we have always been documenting the reasonably foreseeable misuse. That is part of the risk analysis. I would not expect a separate list with just that.
Jonathan Phillips thanks for the kind words. I hope the video helps. And the checklist if you download it. Let me know if you think something is missing.
@@MedicalDeviceHQ Nothing missing as was comprehensive as you can be in that time. I do have a question regarding clinical evaluation...can you advise on any training material or courses? Thanks
Great job! Quite informative. How may we estaminate risk to the barest minimum?
Hi Peter,
The presentation is very informative and thanks for sharing.
I wanted to understand, as a part of new 2019 version of the standard, should we have to specifically list out the reasonably foreseeable misuses about the product?
If yes, where should it be? Is it as a part of intended use & indications of use of the product OR in the Risk management Review file?
Please let us know.
I would say that we have always been documenting the reasonably foreseeable misuse. That is part of the risk analysis. I would not expect a separate list with just that.
I want to know how to perform risk benefit analysis ??
Excellent video. In the process of updating a number of risk management files and starting a brand new one!
Jonathan Phillips thanks for the kind words. I hope the video helps. And the checklist if you download it. Let me know if you think something is missing.
@@MedicalDeviceHQ Nothing missing as was comprehensive as you can be in that time. I do have a question regarding clinical evaluation...can you advise on any training material or courses? Thanks
Very well done . Thank you
Good video really appreciated
Thanks for the kind feedback.