Hi. I've stepped into getting my (new) company prepared for an upcoming ISO 13485 audit. We also need to meet the MDD and have a Technical File. In our ISO pre-audit, there were non-conformances for the existence and adequacy of validation reports.

Is there a required or suggested format that these should take? I've seen the link to clinivation for the validation master plan, but am wondering if there is a format for the specific validation plan itself, and what the auditors will be looking for.

Thanks!

Do you want to know about the validation pla(first step) or the validation report (last step)? Anyway there shouldn´t a format simply because validations plans and reports are very product-specific.

Anyway, there´s an example in the annex of the GHTF Guidance for Process Validation (see http://elsmar.com/Forums/showthread.php?t=24920&highlight=validation+medical+devices)

At this point, it would be for the reports, as a lot of the work has been done and it's mostly a matter of documenting what we have.

In terms of format, I'm wondering if there's a generally accepted, desired, or required layout. As long as we need to put it together, we can structure it accordingly.

There are various types of validation (e.g sterilization, packing, washing..) according to your product or product groups. Our notified bodies related guidance document attached.

Just looking for some general feedback here...

Would any of you consider it unusual to have no processes in a manufacturing environment requiring process validation? We manufacture a electro/mechanical Class II device & our position is that every finished device specification is verified by inspection and testing.

Thoughts??

There are various types of validation (e.g sterilization, packing, washing..) according to your product or product groups. Our notified bodies related guidance document attached.

Thanks for the document. It's a great resource. My device is Class I, so I need a Technical File, but the document covers that and the Design Dossier. There's also a reference to Attachment I: European Norms and Standards and other documents supporting Technical Files and Design Dossiers. It also looks like the document is 15 pages, but your attachment only has the first 6. Is a full version available somewhere? (edit: Oops, never mind on this. I found the full version in another thread just now, and PSS: Root cause was a printer jam, so it never printed fully the first time.)

Also, how do I know where to "stop" for a Technical File, i.e., when is documentation enough compared to a Design Dossier?

I suggest to you this very useful document "GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES by Market Surveillance Operation Group"

There are various types of validation (e.g sterilization, packing, washing..) according to your product or product groups. Our notified bodies related guidance document attached.
Thanks for this Jkonholm - it is always useful to have a guideline from a different NB than you are used to. Just a word of caution to anyone planning to use this document - the standards quoted in this document were correct in 2004 when it was issued, but they have changed somewhat since then. The EN series are withdrawn and there is a new moist heat standard ISO 17665:2006 to replace ISO 11134. Many of these were introduced with little fanfare and may have slipped under the radar.

Jimmy