Hi,:bigwave:

I´m new on this forum and need help. I have to define a structure and the content of DHF and DMR because my firm is expecting an FDA-audit (Class III devices). We sell on the European market and now soon as well on the American market. So the documentation has to be conform with FDA and ISO 13485. Here are my questions:

-Is the DMR the same as the Technical Documentation required in ISO?
-Can the DMR only be a table of content referring to documents of the technical documentation and the DHF?:confused:

Many thanks for soon replies!
Cosma

Welcome Cosma,

Are you talking of ISO 13485 or ISO 14385 as written?

Sorry, my fault:

I mean ISO 13485!:notme:

I´m new on this forum and need help. I have to define a structure and the content of DHF and DMR

In my experience the easiest way to meet both 13485 and FDA is to have the Design History File (DHF) contents match the Regs, e.g. a section for Design & Development Planning.... through to Design Validation, this pretty much matches 13485 and when inspected makes it easy for the inspector to navigate around and gives them a warm feeling.

The DMR is a recipe for making the device, so as well as a list of procedures, forms, records etc that you use to manufacture the device, you will also need drawings, BoMs (Bill of Materials) and packaging specs. In my experience this has been hybrid of listing of hard copy documents, and electronic records (for BoMs, formulations, etc, things held on the ERP system), but you need to make sure that you meet 21CFR part11 for this (FDA reg). Additionally within your ECO (change control system) I would advise a box that asks if DMR requires update so (if removing or adding procedures forms etc) so it is alway up to date.

because my firm is expecting an FDA-audit (Class III devices). We sell on the European market and now soon as well on the American market.

Good Luck:agree1:

-Is the DMR the same as the Technical Documentation required in ISO?

Not just technical, think of it more as a recipe... ingredients (with there spec), method (how to mix ingredients to get end product), the checks/balances you have in place to ensure its done the correct way, and how you pack the product for shipping with the specs for packing material and labels used.

-Can the DMR only be a table of content referring to documents of the technical documentation and the DHF?:confused

The Design History File is a compilation of records that show the device was designed according to the regs, once design is finished it will be transferred to production (desin transfer) the the DMR is created around this time.

Additionally you have the DHR (Device History Record) this is just that, a collection of records, tests, checks that confirm that the device has been manufactured according to your required specification and is fit for sale. The structure for this generally in my experience is a folder with the serial # of the device on the front, that is added to at various stages throughout the manufacture of the device in chronological order. However I have heard that some sites now do this electronically, however again to meet FDA regs you will need to comply to 21CFR part 11.

An Inspector will normally go from a DMR to a DHR, hence the reason to keep your DMR current.

Hope this helps cheers Nigel

Hi,:bigwave:

I´m new on this forum and need help. I have to define a structure and the content of DHF and DMR because my firm is expecting an FDA-audit (Class III devices). We sell on the European market and now soon as well on the American market. So the documentation has to be conform with FDA and ISO 13485. Here are my questions:

-Is the DMR the same as the Technical Documentation required in ISO?
-Can the DMR only be a table of content referring to documents of the technical documentation and the DHF?:confused:

Many thanks for soon replies!
Cosma

Hi Cosma,

Welcome to the Cove :bigwave:

You could refer to FDA website for DMR content (http://www.fda.gov/cdrh/qsr/08dmr.html#device_master_record_contents)

Also refer to this THREAD (http://elsmar.com/Forums/showthread.php?t=11018), which is very informative and hope can address all your queries.

In case, you have further questions, pl come back :)

Thank´s a lot, it ssems to get a bit clearer now!:thanx:

Me again,

is it useful to do the structure as follows (in order to meet both FDA and ISO) :

- DHF
- Technical Documentation (in my firm this is used for Regulatory Affairs, according to 93/42/EC) and has nearly the same content as the DMR

And the DMR as a separate document which is just a table of content referring to DHF and Technical Documentation - just to be conform with FDA.

What do you think?:)
Thanks for your statements,
Cosma