Summary Technical Document (STED) and OEM Technical data

[ISO Newby]

Hi everyone,

I am trying to put together the STED file for one of our devices which is produced by an OEM producer. What is the best way to reference and present the data if alot of it is based on external data?

With many thanks

Iso Newby....

 

[Ajit Basrur]

Re: Summary Technical Doc. and OEM Tech data

Do you have this proposed revised Document from GHTF ?

This has an Essential principles (EP) Checklist and you could attach your documents as supporting to the individual sections of the checklist.

 

[ISO Newby]

Re: Summary Technical Doc. and OEM Tech data

Ajit,

Thank you for your reply. I have the GHTF document. As I understand it there are several main sections in the STED that need to be constructed and the essentials checklists is an attachment. My question is whether I can use their information and use it. If the goal is to provide the information regarding the device safety and effectiveness, then who does the actual act seems less important......However, document reference numbers are not ours... so does that make our STED baseless ?