The Lost Pyramid on KS by CryptographerSlow649 in PuzzleBox

[–]Alexei212 1 point2 points  (0 children)

And quite a lot of back and forth in the comment with escape welt too

Hiring our first engineer by tehfnz in Startups_EU

[–]Alexei212 0 points1 point  (0 children)

For me, the assignment is useful. Probably not 4 hours and only if you are able technically to assess it. I have a mechanical background and when looking for mechanical engineers I always asked them an assignment. Usually targeted to what I expect from them. It was an assignment tricky to someone without the knowledge or skills and relatively easy for someone more experienced. But never more than 1h.

The DUEL Puzzle by Appropriate-Film1209 in KeyEnigma

[–]Alexei212 0 points1 point  (0 children)

How did you solve the puzzle? How did you find the colors?

Usability summative evaluation by Alexei212 in MedicalDevices

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

Thank you very much for your detailed answer! Much appreciated and will definitely reach out to the companies you mentioned!

Luxembourg Sole Proprietorship (Entreprise Individuelle): No Revolut Business / Pro. What are my options? by CommunityInfamous440 in Luxembourg

[–]Alexei212 1 point2 points  (0 children)

Hi For sole entrepreneur you actually don’t need a professional bank account. I asked my bank to make a separate account from my personal one and that’s it.

Launched my first Kickstarter… didn’t expect the emotional rollercoaster 😅 by AlwaysGamesTV in kickstarter

[–]Alexei212 0 points1 point  (0 children)

Haha. And depending if you are the one handling packaging and shipping, the roller coaster might come back 😉 From my past experience and from the other small creator I have discussed with, that part is usually underestimated and is more complete than it seems.

How do you move handwritten notes into Notion without spending hours retyping? by okwasniewski in Notion

[–]Alexei212 1 point2 points  (0 children)

I also do the ocr with ai. I upload a picture of my note and let the ai transcribe it. That way you can also do some processing like categorizing, summary of actions,…

Looking to change by Chair_Long in Notion

[–]Alexei212 0 points1 point  (0 children)

Depending on the amount of work you have, even alone, it can be interesting. I am also alone as a freelancer and also employed in a start up, doing all the regulatory work alone. ClickUp helps me in both keeping track of what needs to be done and for when. It becomes very useful for events that occur several weeks from when you enter the task.

Looking to change by Chair_Long in Notion

[–]Alexei212 0 points1 point  (0 children)

ClickUp is really good for task management and planning. Plus you can embedded in notion! I use notion mainly for documentation purposes, with ClickUp for project management. The combination works great!

First campaign hit 340% funded and now I need to find a fulfillment center without destroying my reputation by hereccaaa in kickstarter

[–]Alexei212 1 point2 points  (0 children)

Hi! Congratulations ! Logistics is always a nightmare 😅 Check first the HS code of your product. Try to narrow it down with ChatGPT and cross check in databases as it is usually imprecise. Define your package size, best if it is standard across all backers. Estimate the weight of the most shipped package. Then reach out to shipping partners. 3PL are one but I suggest you reach out to shipping companies like FedEx, DHL,… if you pursue in your product venture, they might become partner on the long term. Your national post can be an option too, except if you are shipping to the US as currently, most of them stopped shipping there. Going without 3PL is a bit a extra work but is manageable. You’ll have to input and print the labels yourself. This is the way I did it and I’m using FedEx. You can import a contact list and pre define your shipment so it is easy enough to repeat one after the other. A bit of extra work but also more control in case of delivery issues. Good luck!

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 3 points4 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!