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Home > Archive > Electrical code Compliance > September 2006 > Medical Devices - Notified Body
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Medical Devices - Notified Body
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| Stian Sagevik 2006-09-14, 9:25 am |
| Hi
We are a small company developing and manufacturing medical devices,
located in Norway, Europe. Most of our sales are exports worldwide, like
Europe, US, Canada, Australia and Asia.
Until now, our equipment has mainly been used for research purposes and
having an governmental approval has not been necessary.
But now we're also want to sell our product for clinical use, which
implies that our product must comply to regulations given by national
requirements for each country/region where we want to market our product.
Our product is rated as Class IIa according to the Medical device
directive (CE-class IIa) which requires an notified body.
As we also need an FDA approval and probably many more for the different
parts of the world where we want to market our product, I need a
recommendation for choosing the suitable Notified body for us. It's
important that the process getting other international approval are as
simple and effective as possible after getting the CE certificate in place.
I'm grateful for any help!
Stian Sagevik
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| charlieB 2006-09-18, 9:25 am |
|
Stian Sagevik wrote:
> Hi
>
> We are a small company developing and manufacturing medical devices,
> located in Norway, Europe. Most of our sales are exports worldwide, like
> Europe, US, Canada, Australia and Asia.
> Until now, our equipment has mainly been used for research purposes and
> having an governmental approval has not been necessary.
>
> But now we're also want to sell our product for clinical use, which
> implies that our product must comply to regulations given by national
> requirements for each country/region where we want to market our product.
> Our product is rated as Class IIa according to the Medical device
> directive (CE-class IIa) which requires an notified body.
>
> As we also need an FDA approval and probably many more for the different
> parts of the world where we want to market our product, I need a
> recommendation for choosing the suitable Notified body for us. It's
> important that the process getting other international approval are as
> simple and effective as possible after getting the CE certificate in place.
>
> I'm grateful for any help!
>
> Stian Sagevik
You can find a suitable Notifed Body at:
http://ec.europa.eu/enterprise/newa...pe_dir=NO%20CPD
In terms of recommendation - you would be better to chose one local to
yourselves, such as Nemko, www.nemko.com
regards
Charlie
| |
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| Hello Stian,
>
> We are a small company developing and manufacturing medical devices,
> located in Norway, Europe. Most of our sales are exports worldwide,
> like Europe, US, Canada, Australia and Asia.
> Until now, our equipment has mainly been used for research purposes and
> having an governmental approval has not been necessary.
>
> But now we're also want to sell our product for clinical use, which
> implies that our product must comply to regulations given by national
> requirements for each country/region where we want to market our
> product. Our product is rated as Class IIa according to the Medical
> device directive (CE-class IIa) which requires an notified body.
>
> As we also need an FDA approval and probably many more for the
> different parts of the world where we want to market our product, I
> need a recommendation for choosing the suitable Notified body for us.
> It's important that the process getting other international approval
> are as simple and effective as possible after getting the CE
> certificate in place.
>
Talk to TUEV-Rheinland or one of the other TUEV offices if they have one
in Norway. In my experience it is best to select a lab that is close,
within resonable driving distance. Ask whether they can do it all as a
turn-key job and for which countries.
You will have to pass EMC and most of the time the first test fails,
unless you have some EMC experts in house or the design is simple. This
is when it is important to be close to the lab. You might have to
consider winter, that's why I wouldn't use a lab east of here during
that season (mountain roads can close).
--
Regards, Joerg (also in the med elctronics biz)
http://www.analogconsultants.com
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| billb@abc.net 2006-09-19, 5:25 pm |
| Hi Stian
You can try us if you like, I work for the TUV Rheinland Group in the UK and
we can offer the services you need.
Please e-mail us at deletethissafety@removethisuk.tuv.com
If you e-mail us I will send you details of our services and offer any help
we can.
BillB
TUV International UK
+44 (0) 121-353-9962
| |
| mjdanisi@optonline.net 2006-09-27, 9:25 pm |
|
Stian Sagevik wrote:
> Hi
>
> We are a small company developing and manufacturing medical devices,
> located in Norway, Europe. Most of our sales are exports worldwide, like
> Europe, US, Canada, Australia and Asia.
> Until now, our equipment has mainly been used for research purposes and
> having an governmental approval has not been necessary.
>
> But now we're also want to sell our product for clinical use, which
> implies that our product must comply to regulations given by national
> requirements for each country/region where we want to market our product.
> Our product is rated as Class IIa according to the Medical device
> directive (CE-class IIa) which requires an notified body.
>
> As we also need an FDA approval and probably many more for the different
> parts of the world where we want to market our product, I need a
> recommendation for choosing the suitable Notified body for us. It's
> important that the process getting other international approval are as
> simple and effective as possible after getting the CE certificate in place.
>
> I'm grateful for any help!
>
> Stian Sagevik
| |
| mjdanisi@optonline.net 2006-09-27, 9:25 pm |
|
Stian Sagevik wrote:
> Hi
>
> We are a small company developing and manufacturing medical devices,
> located in Norway, Europe. Most of our sales are exports worldwide, like
> Europe, US, Canada, Australia and Asia.
> Until now, our equipment has mainly been used for research purposes and
> having an governmental approval has not been necessary.
>
> But now we're also want to sell our product for clinical use, which
> implies that our product must comply to regulations given by national
> requirements for each country/region where we want to market our product.
> Our product is rated as Class IIa according to the Medical device
> directive (CE-class IIa) which requires an notified body.
>
> As we also need an FDA approval and probably many more for the different
> parts of the world where we want to market our product, I need a
> recommendation for choosing the suitable Notified body for us. It's
> important that the process getting other international approval are as
> simple and effective as possible after getting the CE certificate in place.
>
> I'm grateful for any help!
>
> Stian Sagevik
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