Medical Device Regulatory Standards Update Services

[meddevsd]

Hello,

I am asking for help to find professional services that can provide updates for all our Regulatory Standards for Medical Devices. We are in the Infusion Pumps bussiness with an International market, and will need to be updated for all our Regulatory Standards. Does anybody knows of a firm providing these services? I will appreciate any replies ASAP. THANK YOU ALL!

 

[Stijloor]

Hello,

I am asking for help to find professional services that can provide updates for all our Regulatory Standards for Medical Devices. We are in the Infusion Pumps business with an International market, and will need to be updated for all our Regulatory Standards. Does anybody knows of a firm providing these services? I will appreciate any replies ASAP.

THANK YOU ALL!

Can someone help with this?

Thank you very much!!

Stijloor.

 

[Gert Sorensen]

I know that the Danish Standards association has a service for updating standards, and that is quite reasonably priced. I believe that at least BSI has a similar service.

 

[SteveK]

Hello,

I am asking for help to find professional services that can provide updates for all our Regulatory Standards for Medical Devices. We are in the Infusion Pumps bussiness with an International market, and will need to be updated for all our Regulatory Standards. Does anybody knows of a firm providing these services? I will appreciate any replies ASAP. THANK YOU ALL!

As Gert indicates BSI does have an updating service call PLUS as part of their membership (as a member you get standards half price). You have to supply a list of all the standards that you are interested in. You are charged for this. You then get a monthly notification of any changes. In our case we are automatically supplied with the new standard (at the half price cost). In the case of a new corrigendum etc this is not charged for. You also get a monthly publication of what is happening with standards (covers BS, EN and ISO) – also available online. This is useful because the automatic PLUS updates do not indicate if there is a particular new standard that is relevant to your particular area (because it would not be on the list). I do not know if it covers (or can) DIN, ASTM etc standards.

Steve

 

[meddevsd]

Thank you for your reply!

 

[meddevsd]

Thank you for the information. We currently have IHS with similar services, but we are looking for a services povider that can monitor all our standards (J-Pal, ISO, IEC, EN, ASTM, European Directives, IEEE..etc) and update on any new standards that may apply to our products as soon as the standards are released......Does anybody may know of a company providing these type of services??? Thank you!

 

[Gert Sorensen]

I am not quite sure whether it is possible to have all standards etc. monitored by one service provider, but I seem to recall that the Danish Standards Society - www.ds.dk - is willing to monitor at least the american ANSI/AAMI standards besides the various European versions ISO/IEC/EN.

In my experience it is not necessary to have all standards monitored this way, what is important is to have the bulk of them monitored and thus remove a large workload because you only have to look for changes to a very minor portion of your standards then.

While you are at it, give consideration to your licensing terms for the standards - if you are not already using network enabled versions of them, you may find that a switch to this may be a good idea.

 

[J0anne]

Hello,

I am asking for help to find professional services that can provide updates for all our Regulatory Standards for Medical Devices. We are in the Infusion Pumps bussiness with an International market, and will need to be updated for all our Regulatory Standards. Does anybody knows of a firm providing these services? I will appreciate any replies ASAP. THANK YOU ALL!

My company provides this service with previous experience of infusion pumps. If you would email me privately I can prepare a highly competitive quote that will cover your global market requirements.

 

[meddevsd]

My company provides this service with previous experience of infusion pumps. If you would email me privately I can prepare a highly competitive quote that will cover your global market requirements.

Hello Joanne,

Thanks for your reply!
I will be e-mailing you from your website .

Regards,