Very good Definition of Risk: Combination of the probability of occurrence of harm and sevarity of that harm

Great presentation. I laughed too on the Cytotox failures which are driving we engineers insane by proxy!

Hi Audrey, Good outline about biocompatibility ISO10993. I need one clarification about CMR substances in MDR. Is there hazmat screening test helps to identify CMR in materials ? Please give your comments.

Great presentation; a quick question, do I need to do chemical characterization on a permanent device (implant) if the materials are not new? Only the geometry is different.

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I know this is 3 years old, but I do have a question. Let's say that a system extracts fluid from the patient into a bag. What type of contact characterizes parts that are outside the body such as external tubing and bags that collect blood? Thanks!