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(Admin code added by Palmer - : 7CE89792W9196830P) Project Summary: What text should be included in the main part of the logo? Company name is: Next Generation Safety What type of product or service do you offer? We are a public safety device/medical ...
Started by on , 28 posts by 5 people.  
Can you give me some more different version of the "slash" over the NG? Maybe a lightning bolt and another one with a medical "EKG.
It to have more of a "medical " look.
Hi all: We are designing an apps which can measure some body signal such as the blood pressure, and i know we have to submit 510(k) because it is an accessory/part of the medical device. If we decide to measure other type of body signal by such apps, ...
Started by on , 8 posts by 6 people.  
Answer Snippets (Read the full thread at elsmar):
If we decide that a device only measure the body weight which does claim any medical puepose will not be considered to be a medical ....
We have to submit 510(k) because it is an accessory/part of the medical device.
1) Is a device called "articulator" used in dental labs to mount the cast models for work on them, a "medical device" that requires CE mark? 2) If not, what's the best way to convince customs that it is not? 3) If yes, does anyone know any applicable ...
Started by on , 5 posts by 3 people.  
Answer Snippets (Read the full thread at elsmar):
A) ‘medical device’ means any instrument, apparatus, appliance, software, material or other article; By face value, this would not count as a medical device; at most, as an accessory, provided that's mentioned in the MDD....
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Do you know of any companies for sale in the medical device arena?
Started by on , 2 posts  
Everyone is for sale for the right price!!!.
DHS warns of implanted medical device security vulnerabilities More...
Started by on , 1 posts by 1 people.  
Answer Snippets (Read the full thread at tusclan):
Dear all, I have a confusion on the medical device listing, any expert help me to anlysis it? Company A has manufactured a medical device named "A", which can complete the intended function itself. Company B has manufactured a medical device named "B"...
Started by on , 3 posts by 3 people.  
Answer Snippets (Read the full thread at elsmar):
Company B has manufactured....
Dear all, I have a confusion on the medical device listing, any expert help me to anlysis it? Company A has manufactured a medical device named "A", which can complete the intended function itself.
Here's my question: 21CFR 880.6310 defines a Medical Device Data System (mdds) as a Device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i)...
Started by on , 6 posts by 4 people.  
Answer Snippets (Read the full thread at elsmar):
I) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance ....
Hello Everyone.... Can someone help me to have information about the medical device regulation in Cambodia??? Any help is really appreciated.... Thanks in advance for everyone...
Started by on , 2 posts by 2 people.  
Answer Snippets (Read the full thread at elsmar):
As Cambodia is part of Asean, see: ASEAN Medical Device Regulatory Integration.
Under what circumstances would a medical device battery need a CE mark on the battery pack itself? The battery would be a backup power supply and made custom to the device, so it will be used in anything else.
Started by on , 8 posts by 3 people.  
Answer Snippets (Read the full thread at elsmar):
Of this Directive, the following definitions shall apply: (a) ‘medical device’ means any instrument, apparatus mark...that would be when the battery is not specifically intended to be used with the medical deviceYour device....
Hello Everyone, Is there a website that I can download free medical device symbols? Also, I am looking for your recommendation on which label software to purchase for a low volume medical device product. Thanks in advance
Started by on , 8 posts by 8 people.  
Answer Snippets (Read the full thread at elsmar):
There is an electronic version available with all the symbols ready .
In the labelling of medical devices.
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  • Medical Devices Medical Information Technology Medical Software and Health Informatics
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