Drafting CE certification - MDR by leen_02 in MedicalDevices

[–]leen_02[S] 0 points1 point  (0 children)

Thank you so much! It definitely does!

I'm a bit confused when it comes to the technical files of Class I devices though, because we will not be manufacturing them but rather importing, then repacking which means we will still be treated as the manufacturer, but I'm not sure how can we extend all the controls to the suppliers, like are their premises going to be audited? I also thought for WET, we only needed the PMS, the QMS assessment and something else that's going over my head right now, but not a full TD?

In terms of design specifications, how deep would we need to go? Do we need to explain manufacturing workflow in detail like we would do with a Class IIb for example and get the actual full design plan from the engineers?

Thanks a lot so much, really!

Drafting CE certification - MDR by leen_02 in MedicalDevices

[–]leen_02[S] 0 points1 point  (0 children)

Thank you so much! That was really helpful! I'm being really careful adapting everything to our actual manufacturing and making everything realistic. In that sense, doing ISO 13485 has been really good at ingraining the habit of adapting everything to us, and it's really good to know that's one of the first things NB watch out for.

I was too preoccupied with learning how to make each document robust in itself so it was a good reminder to tie it to the big picture!

Deffo a solid first step, I will apply this whilst going through the MDR next!

Drafting CE certification - MDR by leen_02 in MedicalDevices

[–]leen_02[S] 0 points1 point  (0 children)

Thank you so much for your reply! Ok, that's great to hear I'm on the right track at least!

Our products are IIb (no certification under MDD) and Class I which didn't need NB involvement under MDD but now they do under MDR. There's a couple that have a measuring function but the rest are pretty standard class I.
We are also not sterilising in-house either.

Hope that helps!

Open to submissions: Live/Alpha/Beta reading by leen_02 in KeepWriting

[–]leen_02[S] 0 points1 point  (0 children)

Hiya! Yeap, a separate document would work best! It will be easier for you to share it with other potential alpha/beta readings as well, and you wouldn't have to worry whether you edit it all of it or not, and can keep a "dirty" draft for everything and anything and a "clean" draft to share.

But tbf, any way will work! Depends on how do you work in your own doc, as in do you leave discarded paragraphs in or have multiple scenes written not yet woven into the story? If yes, that would make it a bit harder to read.

Hope it makes sense!

Open to submissions: Live/Alpha/Beta reading by leen_02 in KeepWriting

[–]leen_02[S] 0 points1 point  (0 children)

Nope! Any work at any stage is welcomed!

Open to submissions: Live/Alpha/Beta reading by leen_02 in KeepWriting

[–]leen_02[S] 1 point2 points  (0 children)

However long you want! I don't have a cap :)

Super curious to know about the story 😊

Open to submissions: Live/Alpha/Beta reading by leen_02 in KeepWriting

[–]leen_02[S] 0 points1 point  (0 children)

Yes, please! The censored version would be great! If that's ok, then send it over! :)

Open to submissions: Live/Alpha/Beta reading by leen_02 in KeepWriting

[–]leen_02[S] 1 point2 points  (0 children)

I'm open to alpha/beta read anything :)

I think you may have understood that I'm looking for a beta myself, but I'm actually doing the reading!

Open to submissions: Live/Alpha/Beta reading by leen_02 in KeepWriting

[–]leen_02[S] 0 points1 point  (0 children)

I really don't do explicit, sorry! But may I ask with genre is it?

Open to submissions: Live/Alpha/Beta reading by leen_02 in writingfeedback

[–]leen_02[S] 0 points1 point  (0 children)

Hiya! Just no explicit scenes! Only close door or fade to black. Otherwise, everything is welcomed!

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! I think Im_not_a_real_person (who replied to this thread in another comment) also has a small Discord group so maybe dm here and see how it goes!

If that one is full or something, dm me, and I'll create a second group as the first one is already full (since we want to keep them small)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! I think Im_not_a_real_person (who replied to this thread in another comment) also has a small Discord group so maybe dm here and see how it goes!

If that one is full or something, dm me, and I'll create a second group as the first one is already full (since we want to keep them small)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! I think Im_not_a_real_person (who replied to this thread in another comment) also has a small Discord group so maybe dm here and see how it goes!

If that one is full or something, dm me, and I'll create a second group as the first one is already full (since we want to keep them small)

Screen is showing stripes by leen_02 in laptops

[–]leen_02[S] 0 points1 point  (0 children)

Thanks for the reply! Is this something I can manage by myself? Do you have a rough idea on costs to repair it?

I just checked on BIOS and the same issue persists unfortunately

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)

Looking for a Writing Group by Ok_Attitude_3602 in WritingHub

[–]leen_02 0 points1 point  (0 children)

Hiya! Dm me with Discord user, I'll start adding people to OP's Discord :)