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Archive for category: General Regulatory Issues

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Solve your upcoming FDA UDI Database Challenge with our new Samarind Medical Device Solution

Are you on top of all this UDI stuff?  And if not – shouldn’t you be? What I mean specifically, is that the USA’s Food and Drug Administration has recently made a ruling that anyone selling medical devices in the US has to add a new ‘unique device identification’ (UDI) to all of its labeling.

Plus – you also have to send details of your devices that regulator’s global unique device identification database The problem is, I suspect that many medical device manufacturers are not fully aware of what this entails, and those that do, have not yet set about creating a good system to meet the requirement.

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Is it time to turn your reporting structure ‘upside down’?

How familiar are you with the current issues around eCTD, that is Electronic Common Technical Document?  (If your primary interest is Europe, see here for more information: http://esubmission.ema.europa.eu/ectd/  and if your interest is in the US, see here)

If you are unsure about the term, which I admit isn’t that user-friendly perhaps, then the good news is it’s not that hard to unpack. All eCTD really means is a standards-based way the industry is going in to move from delivering drug marketing applications to regulatory authorities not in paper, but in an electronic format. The main drivers include a push by the ICH (International Conference on Harmonisation) process – which is to say US, Japan and Europe – which wants to use one common format: hence eCTD. (Please note this is for information on human drugs alone, although there is work going ahead in the veterinary field as well as in cosmetics.)

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