I realise that this is already quite an "old" thread (I refer to the OP and the responses directed at them), but for the sake of future visitors I'd like to comment a bit further.
@ChrisM Your responses make perfect sense to me, but I think they're more applicable to situations where both parties (moulder and client) are fairly well-established in the business of making medical devices (and where there ARE, actually, two such parties involved). I have seen similar situations before, and I have a feeling that this is not the case here. I think that this might be an instance of the following situation: A non-medical injection moulder (established to some degree) comes across a perceived "business opportunity" involving manufacturing of simple medical devices (or their components), either as an own brand or under a manufacturing-only contract. Many times in such situations there is no clear set of requirements or even a well-defined client, and normally regulatory knowledge (or even specific-niche QA knowledge) is lacking in-house. So asking the "right" questions doesn't really help - there is no one who is able to answer them properly, and typically when the decision makers begin to understand the implications of going into medical manufacturing, the "opportunity" stops looking promising and the endeavour is abandoned. No offence to anyone and I'm not saying that this is necessarily the situation here, but my experience/hunch tells me that it's possible.
@Markus 83 Regardless of what/who drives the endeavour, there has to be a good understanding of what the device is ("baby care" is very general), what it's required/expected to do/achieve (and how), and what are the minimum conditions that will allow that. For example, what are the minimum cleanliness requirements. When the device is non-sterile (and not intended for sterilization), a cleanroom is not an obvious requirement. There may be more ways of meeting the relevant cleanliness requirements, so you have to first understand what they are and then choose (considering total cost, among other factors). If you don't have to have a cleanroom in order to achieve the necessary cleanliness, you're probably better off not going down that path.
For class 1 (USA), the device classification is determined by identifying a specific, similar (equivalent) class 1 device model that is already legally marketed in the USA. This means you'd have some knowledge about the expected cleanliness - what are the claims/descriptions in the labeling, and what can you learn from them about the device / the use? How is that device packaged? Etc. Sometimes the applicable regulation will also tell you something about technical requirements (e.g. cleanliness), but it's not likely for class 1 devices. If you cant identify a similar device that is in class 1 (or you realize that equivalent devices are actually in class 2), it's not likely that your device is indeed class 1, and the situation gets more complicated. Now, cleanroom classifications have nothing to do literally with device classifications. In cleanrooms, the lower the number is, the "cleaner" the cleanroom is. Most injection moulding cleanrooms are class 8, but sometimes class 7 is necessary (the difference between class 8 and class 7 is not small, in terms of infrastructure, costs and effort). Other classes are not common in non-formulated medical devices manufacturing (more common in semiconductors).
