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gh56 replied to the topic Discussion Topic: Post-market surveillance in the forum Device Documentation 8 years, 7 months ago
I have to agree with Jnm22 and mj34 but I want to add a little more about this that I think is important. We first need to understand that post-market-surveillance is to pretty much monitoring a device after is out in the market. Mostly how we going to monitor these devices is by the consumers, which would be our customer, they can be doctors, patients, etc. so a way to try to surveillance this devices it can be complicated. The way to do some PMS is by doing some proactive actions type for example, performing customer surveys, try to do some post CE mark clinical trials, including PMCF, manufacturer sponsored device tracking/implant registries, or expert user groups. Another way is to get some reactive actions, for examples, getting customer complains about the device, or getting maintenance/service reports, by social media.