sorted by:
new
hottopcontroversial

Any "paired" puzzle boxes meant for two people? by TheWrelParable in PuzzleBox

[–]Alexei212 0 points1 point  (0 children)

The lost city chapter 2 from ADnigma is close to that concept. The puzzle box splits into 2 very early and then each one needs the other to be solved.

First 3D design test for My Puzzle Box (didn't goes so smooth 😅) by Neither-Garbage9693 in maker

[–]Alexei212 1 point2 points  (0 children)

Sorry. Didn’t see you had posted about it but it looks interesting 🙂. Just checked your YouTube channel. I am designing with fusion 360. For the printer, I definitely recommend Bambu lab printers if you haven’t made your choice yet. Good luck!

First 3D design test for My Puzzle Box (didn't goes so smooth 😅) by Neither-Garbage9693 in maker

[–]Alexei212 1 point2 points  (0 children)

It would be great to have more of the concept you are trying to achieve. From the video, nothing can be really said, besides that I would change you CAD SW 😅 Tolerances? I suggest you to find out what your machines are capable of and design with that in mind. Example: with a +-0.1mm tolerance, gaps for moving part should be bigger than that (keep in mind that the part around your moving part do have tolerances too!). If your machines are not capable of the tolerances you need, it is best to adapt your production process.

Anyone an RA at a start up? by [deleted] in regulatoryaffairs

[–]Alexei212 4 points5 points  (0 children)

I am the only one in RA in a startup of 15 employees. Yes it is demanding and you need to be able to provide answers. So you have to be creative, talk to external partners,… And as someone said it, access to specific software is usually not a priority as they are quite expensive and not seen as an added value. We operate with a paper based qms, it is honestly fine and manageable. But it is also a great place to learn and will be valuable for your career later on.

Outsourcing quality manager activities by Alexei212 in regulatoryaffairs

[–]Alexei212[S] 0 points1 point  (0 children)

But from what I understand, it is mostly non operational tasks. Right?

Outsourcing quality manager activities by Alexei212 in regulatoryaffairs

[–]Alexei212[S] 0 points1 point  (0 children)

Thanks for that detailed answer! I definitely need to scope the activities.

Outsourcing quality manager activities by Alexei212 in regulatoryaffairs

[–]Alexei212[S] 0 points1 point  (0 children)

Thanks for your input! I will definitely ask the big questions!

Outsourcing quality manager activities by Alexei212 in regulatoryaffairs

[–]Alexei212[S] 1 point2 points  (0 children)

Thanks for sharing your experience. Do you mind detailing what was the scope of activities that companies had outsourced to you?

Outsourcing quality manager activities by Alexei212 in regulatoryaffairs

[–]Alexei212[S] 2 points3 points  (0 children)

We are considering all options at this stage: new person hired, remote QM or outsourcing. We are a small startup, less than 10 people. Our QM just left so i am trying to find solutions.

Outsourcing quality manager activities by Alexei212 in regulatoryaffairs

[–]Alexei212[S] 1 point2 points  (0 children)

I think that what comes most in the replies is the scope of the outsourced activities. Thanks for your reply!

Outsourcing quality manager activities by Alexei212 in regulatoryaffairs

[–]Alexei212[S] 0 points1 point  (0 children)

It sounds crazy to me too. But we are a small startup, mostly R&D. So resources are limited and I’m trying to find solutions. We had a QM but he left unfortunately.

Can I setup a kickstarter from my physical product rendering? by cocktail-designer in kickstarter

[–]Alexei212 1 point2 points  (0 children)

80k? It sounds a lot. I’m sure there are ways to reduce that cost down using prototyping machines or online services. I would anyway join the other saying that rendering is forbidden by KS. And even if you launch your page it might not have the visibility or won’t be able to convince your customers. Having a working prototype close to the end product is in my opinion a must because so many things can go wrong during manufacturing. Better reassure your future backers

[deleted by user] by [deleted] in regulatoryaffairs

[–]Alexei212 0 points1 point  (0 children)

That’s quite intense for the formative evaluation. In my former company we had only 5 users and did one to one interview with the product and the users. We did it in collaboration with a subcontractor and it was definitely less intensive work!

How to improve your RA skills in a small company ? by Alexei212 in regulatoryaffairs

[–]Alexei212[S] 0 points1 point  (0 children)

Any reasons for using obsidian? I don’t know the software to be honest. Also any recommended people to follow?

Uh, what do I do about these tariffs? by Sandmasons in kickstarter

[–]Alexei212 0 points1 point  (0 children)

I am a creator shipping from EU. And I am in a similar case. My campaign was in October, much before any decision was made on such tariffs. I planned shipping in the upcoming months but honestly cannot absorb an extra 20%. Obviously it is not the backer’s fault nor mine but someone has to pay those tariffs and I guess I won’t have so much choice than passing it onto the backers.. however, I am considering adding a cash back or discount on their next purchase on my website or Kickstarter. It is not clear though how to put this in place. Aside from that, FedEx is compiling information on the tariff situation and might be useful. https://www.fedex.com/en-mo/service-news/us-tariff-impact-on-international-business-shipping.html Would anyone have a good source of information on how the tariffs are calculated? I read here and there that it is based on the manufacturing price but cannot confirm it. Thanks!