Air Collective Forum

Certifications in Bulgaria

@Nato @Bo_RSNTR @Momchil_MedLease I just spoke with Leon, an embedded software engineeri in Plovdiv who’s worked on US medical devices. He advised us:

  • To work device by device, asking the Ministry Of Health what are the minimum certifications necessary. This includes our PPE and masks.
  • Alternativeiy, we might elicit a faster, more favourable response if we specifically ask if certification X is acceptable for device Y, as a yes or no question.
  • To investigate already-purchased devices in hospitals, to see what foreign certifications they have, to determine what is adequate
  • When he described the general certification processes, he pointed out that CE certification, if appropriate can be done in facilities similar to those I’ve seen at Tech Park.

He’s worked with Olimex before, so will put me in touch with them, and I will continue this exploration with them.

Please let me know if you have any input on this. I will turn some more attention to this once we release the fundraising campaign.

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Thanks for the update @salim. I think the second approach (asking a Yes/No question) would be better. We can start off with writing an official general letter and then once we have established communication, we can go into details. This was the approach with both Alexandrovska and the Doctors Union.

The only question is when to send this letter? I can do it early next week, so that when we are ready with the campaign, they’ll be already aware? Or we can have some traction and then get in touch with them.