We are submitting a bid for sales. The potential customer has asked for MDS 2 information. No one seems to know the who, what, when and where, for this inquiry.

Does anyone have experience with this?

:thanks:

We are submitting a bid for sales. The potential customer has asked for MDS 2 information. No one seems to know the who, what, when and where, for this inquiry.

Does anyone have experience with this?

:thanks:

Hello TJG954,

Would this be a start?

http://www.himss.org/ASP/topics_FocusDynamic.asp?faid=99

Stijloor.

Just in case you're in the same boat.........

MDS 2 = Manufacturer Disclosure Statement for Medical Device Security

The intent of the MDS2 is to supply healthcare providers with important information that can assist them in assessing the vulnerability and risks associated with electronic Protected Health Information (ePHI) transmitted or maintained by medical devices. Because security risk assessment is a broad, organization-wide effort, this document focuses on only those elements of the risk assessment process associated with medical devices and systems that maintain or transmit ePHI.

We are submitting a bid for sales. The potential customer has asked for MDS 2 information. No one seems to know the who, what, when and where, for this inquiry.

Does anyone have experience with this?

:thanks:

For those like me who are ignorant of medical-device requirements, I learned from my good friend Google that it stands for Medical Device Security. If you go here (http://www.sunshine-healthcare.org/ASP/topics_FocusDynamic.asp?faid=99) there's an explanation. Scroll down to the bottom of the page and there is a link to a form that might be helpful, as well as links to a couple of presentations. Also, there's never any harm in asking the customer what they want, if the initial requirements aren't clear. :D

For those like me who are ignorant of medical-device requirements, I learned from my good friend Google that it stands for Medical Device Security. If you go here (http://www.sunshine-healthcare.org/ASP/topics_FocusDynamic.asp?faid=99) there's an explanation. Scroll down to the bottom of the page and there is a link to a form that might be helpful, as well as links to a couple of presentations. Also, there's never any harm in asking the customer what they want, if the initial requirements aren't clear. :D

Hi Jim,

Two minds thinking alike?

Thanks for the direction........

The customer has provided a specific questionaire. We're just not sure who is responsible for completing it. :bonk:

We use a vendor's software in our product; it is not created by us. Should we forward the questionaire to the vendor (with an expected slow response, if any) or is it our responsibility to complete?

Hi Jim,

Two minds thinking alike?
And at the same time, no less. :D