Class for a Medical Device Electronic Part
- Thread starter qusys
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Re: Class for medical devices information
Class I, II etc... I am reading the European Directive.
Class I, II etc... I am reading the European Directive.
sagai
Quite Involved in Discussions
Re: Class for medical devices information
For me those classes are for finished medical devices, whereas your chip is not subject to the legislation own its own.
So for me such classification for the chip itself that is a component of a finished medical device is not really sensible due to the fact that the legislation is for finished medical devices.
... I am not sure if you are more in with this than out though ...
Cheers!
For me those classes are for finished medical devices, whereas your chip is not subject to the legislation own its own.
So for me such classification for the chip itself that is a component of a finished medical device is not really sensible due to the fact that the legislation is for finished medical devices.
... I am not sure if you are more in with this than out though ...
Cheers!
Re: Class for medical devices information
The EU device directive classification only applies to the final medical device - not to components of the device.
The classification criteria can be found in Annex 9 of the directive.
The classification of a pill-camera is, I think, controlled by Rule 5 - Invasive Devices.
From that it is:
Class 1 if for transient use (less than 60 minutes)
Class IIa if for short term use (less than 30 days)
Class IIb if for long term use (more than 30 days).
But if it connects to another device with a higher classification it inherits the higher class.
The EU device directive classification only applies to the final medical device - not to components of the device.
The classification criteria can be found in Annex 9 of the directive.
The classification of a pill-camera is, I think, controlled by Rule 5 - Invasive Devices.
From that it is:
Class 1 if for transient use (less than 60 minutes)
Class IIa if for short term use (less than 30 days)
Class IIb if for long term use (more than 30 days).
But if it connects to another device with a higher classification it inherits the higher class.
Re: Class for medical devices information
Thanks for response, we are on the same line.
I am reading the Directive.
In your opinion, could a foundry ( ISO TS certified and with no design of the product) that produce some component that can find application in medical devices be certified vs ISO 13845? Is it an opportunity?
Thanks for response, we are on the same line.
I am reading the Directive.
In your opinion, could a foundry ( ISO TS certified and with no design of the product) that produce some component that can find application in medical devices be certified vs ISO 13845? Is it an opportunity?
Re: Class for medical devices information
Thanks for response Pad.
Please , advice also about the opportunity to pursue ISO 13845 certification as well
Thanks for response Pad.
Please , advice also about the opportunity to pursue ISO 13845 certification as well
sagai
Quite Involved in Discussions
Re: Class for medical devices information
I think it is up to the discretion of the manufacturer that subcontracts the foundry.
Or the foundry may find itself in a situation that the certificate gives a kind of competitive advantage for them. Otherwise I would not go for it from the perspective of the foundry.
... but to be honest, recently not a rocket science to be ISO13485 certified ...
Cheers!
I think it is up to the discretion of the manufacturer that subcontracts the foundry.
Or the foundry may find itself in a situation that the certificate gives a kind of competitive advantage for them. Otherwise I would not go for it from the perspective of the foundry.
... but to be honest, recently not a rocket science to be ISO13485 certified ...
Cheers!
Re: Class for medical devices information
You could gain ISO 13485 certification if you wanted. However there is no regulatory requirement for you to hold this certification as you are not the manufacturer of a medical device.
I would suggest you speak to your customers as they will be the ones that specify the requirement. They may be willing to accept your existing QMS.
You could gain ISO 13485 certification if you wanted. However there is no regulatory requirement for you to hold this certification as you are not the manufacturer of a medical device.
I would suggest you speak to your customers as they will be the ones that specify the requirement. They may be willing to accept your existing QMS.
Re: Class for medical devices information
Thanks .
Yes, it is related to the competitive advantage. The foundry is ISO TS and some components can be used in medical devices as component of the final product ( pillcam). Considering the process already in place and the very stringent conditions in automotive market, the pursing of ISO 13845 could be a further improvement step. I have seen that there is also product risk assessment according to another standard, then I have seen other additional requirements but the previous track of automotive standards could be useful.
Thanks .
Yes, it is related to the competitive advantage. The foundry is ISO TS and some components can be used in medical devices as component of the final product ( pillcam). Considering the process already in place and the very stringent conditions in automotive market, the pursing of ISO 13845 could be a further improvement step. I have seen that there is also product risk assessment according to another standard, then I have seen other additional requirements but the previous track of automotive standards could be useful.
