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Do members (and I hope to include equipment vendors) know of the regulatory status of the currently used equipment in various laboratories and centres. For example some labs are located within hospitals and have a number of patients going through their measurement equipment and analysis software. What I am specifically asking is if the equipment you have are approved devices (i.e. medical devices) and have you received documentation to show that they meet the regulatory requirements.
I would like to invite comments as well as specific verification from lab managers (or vendors) on specific equipment make and model. For example if you know the device is approved as a medical device then you might also be able to comment on its classification as well.
Some centres make their own equipment (that includes software) or make own modifications to the purchased equipment. I would also like to invite comments as well as information from members, users of such equipment, lab managers as well as vendors. Do you have any information on how such modifications may invalidate the approval status of the device (if it was approved as a medical device in the first place) and render it non-compliant.
How such information is treated, kept and updated in the labs and how the regulatory status of the equipment influence the use of these device on patients (or healthy volunteers). These are the issues that I hope the biomechanics community can comment on.
hamid Rassoulian
I would like to invite comments as well as specific verification from lab managers (or vendors) on specific equipment make and model. For example if you know the device is approved as a medical device then you might also be able to comment on its classification as well.
Some centres make their own equipment (that includes software) or make own modifications to the purchased equipment. I would also like to invite comments as well as information from members, users of such equipment, lab managers as well as vendors. Do you have any information on how such modifications may invalidate the approval status of the device (if it was approved as a medical device in the first place) and render it non-compliant.
How such information is treated, kept and updated in the labs and how the regulatory status of the equipment influence the use of these device on patients (or healthy volunteers). These are the issues that I hope the biomechanics community can comment on.
hamid Rassoulian