I much preferred the question that arrived in my inbox to the one that I assume you edited it to be, so I'm going to answer that one instead:
Are you for or against people asking questions on this forum?
I'm decidedly in favor of questions like these. I think I've commented elsewhere that these types of forums are always labeled "Discussions," but there is usually very little discussing going on, mostly just Q&A. Where there is discussion, it tends to be limited to the relative merit of the As, not infrequently leading to something a bit warmer than a "discussion."
As for this forum, what I like is mostly moot, because this is not a forum where you are likely to get a lot of thought questions. Sometimes discussions do break out, and I like that. I have further found that discussions are more likely to break out in a forum after I start discussing things, instead of just answering questions. Forums are what you help make of them, and like attracts like. (One thing I think might make the Cove's medical device forums stronger is if they were moderated exclusively by people in medical devices, but that's a topic for another day.)
That said, I am not on a mission to turn Q&A forums into discussion forums. I find some of the Q&A to be of interest and value to me. That is why I'm here. If I post discussions instead of answers, that's just me being me. If it encourages others to do a bit more discussing than just Q'ing and A'ing, for me that's a good thing, but it's not a goal of mine.
There are types of questions I like better than others. Those that I don't like, it's less the question than the fount from which it sprang, as well as where it is likely to lead.
The classic is someone who has never been active in the forums and shows up with a question. Actually, lots of questions, but you have to start somewhere. The quickly approaching MDR date has brought them out in record numbers. In addition, if you are experienced in medical device RA, it is painfully easy to tell who is clueless. These are people who work with either clueless startups (typically, an unholy union of academics and VCs) or very marginal established device companies that have never had any RA anything. Often no QA anything, for that matter.
The clueless startup may have hired someone (employee or consultant) they thought was RA, but a RAC does not an RA expert make. (Nor does prior experience auditing anything, nor a does a JD, nor does previous employment by a regulator.) The painful irony here is that no one needs serious RA more than a startup. But most of them will not get it. Most of them will also fail, almost always slowly, rather than fast, taking a lot of other people's money with them, which was really the point, not actually starting anything. Certainly not developing a "break-through, life-saving, innovative, market-disrupting" medical device that will "improve patients' lives!"
Usually the established companies are marketing Class I devices that are, in the US, 510(k) exempt, and in the EU, self-certified. Not infrequently, marketing their products over the internet. They have no RA because they are essentially unregulated, so what would you need RA for? Nothing...until you get "up-classified." These companies could probably hire at least a reasonably competent RA professional if they wanted to, but they don't. That's why there were selling essentially unregulated product in the first place. to avoid all things RA. At most, they have people engaged in "product registration," who think they "doing RA," but at that level, they are truly "just paperwork" professionals that often get confused with RA professionals. Oh, and there are those that think they are "in RA" because they work in regulated industry. Sigh.
[Just for some comic relief, I get a kick out of reading these kinds of ads on Amazon: "FDA Lipstick: Our Lip Gloss all have FDA test. Materials are Warranted and Trusted." Many of the most marginal device companies in the world also sell cosmetics, no surprise there. I don't think this crowd is likely to be asking questions on Elsmar, because I don't think they could find their way here with a map and flashlight.]
So that's where these questions come from. Where they are leading is also discouraging.
There is the person who bought a job ticket from RAPS, snagged a job with a clueless startup, and is now in the process of wasting some part of their lives thinking they are "in RA," when they are not, and therefore no glorious RA career is going to unfold in front of them. They are not in RA, and may well never be in RA. It's a mindset, not a body of knowledge, not a certificate. If you don't have it, the sooner you realize that and find a career that is a good fit for the mindset you do have, the better for you, the better for the world in general.
As for where it leads in terms of the companies they work for...if it's an academic startup, probably to a slow death, but, on the bright side, it "created jobs!" Not very good ones, mostly, and not for very long, but, hey, it's a myopic world we live in. If it's a marginal device company, these days it is often the small business owner asking, or some poor schmuck they tasked with sorting out the MDR. What they really want to know is whether to pull their devices from the EU, whether they can go 510(k) exempt in the US, and not infrequently, whether maybe it's time to close up shop entirely and move on to something else. If they tasked it out, they didn't tell the poor schmuck this, so the more motivated, the more clueless questions they earnestly ask, not understanding where the answers are likely to lead them.
And then there is the whole question of value of regulatory advice (or any other kind, for that matter) given freely, but even more so, freely over the internet by someone you don't even know. If nothing else, it's pretty awkward (and I have seen it happen) when the boss asks a junior staffer how they know that something is "required," and the junior staffer is suddenly struck by the realization that "somebody on the internet named yodarocks told me so" is not an answer they want to give the boss. Nor an intelligent answer, no matter who they might be giving it to.
I think I'm just going to stop here. Much more I could say, but probably more than enough already.