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F

FongPi

#1
Hello fellow forum members,
I work at a small medical device software startup as many of you have experienced, in companies of this everyone wears lots of hats. While this can make for a very interesting learning experience, it can also be very nerve racking when the task at hand is as something as important as writing a tech file. So my question to you is: What is your advice on the best way to learn how to write a tech file? What are some of the best online resources one can call upon to learn the process in and out? The MDD is very difficult to read for someone without regulatory experience, and I’m essentially looking for something along the lines of “Technical Files for Dummies.” After reviewing the materials that are supplied by the EU I feel like there must be tons of resources that help decode that is being said, and how to correctly address the requirements.
Also, what is the best methodology in preparing addendums or supplements (are they same?) to the tech file? Does a living document mean that a history of the file does not need to be maintained?
Any advice is appreciated! Thank you for taking the time to read my post!
 
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sreenu927

Quite Involved in Discussions
#2
Hi FongPi,

There are many in the web. I won't say this is the best, but one of the best ways to develop expertise in writing tech files is, take the essential requirements checklist and try working on it step by step. Understanding the ER is the foremost important thing. And again, different people will have different interpretations. Once you are able to complete the ER checklist, remaining things are quite straightforward. You can prepare your technical file in two parts - Part A is with Table of Contents and brief description of each section/chapter and referencing the document part number for the evidence. Part B includes all test reports/docs that were given as reference. If Clinical Trials are included, then it would need experience in writing the clinical evaluation summary report. If done by Principal Investigator, then it's fine (I am not sure who is responsible for this!!)

Attached is one of the useful documents for understanding EU Medical device regulations strategy and registration process including post market vigilance activities.

Regards,
Sreenu
 

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S

SteveK

#3
Additionally have a look at this on the NB-MED site:

http://www.team-nb.org/index.php?option=com_docman&task=doc_download&gid=1205&Itemid=38&lang=en

I have submitted a number of technical files (Class IIa) to NBs and they have been ‘approved’, so I must be doing something right.

The attached is my version of the TF Contents; I use hyperlinks to navigate around as TFs can end up being large (pdf) documents, especially if when you include design history – which can include many stages of development/changes over the years i.e. contain internal reports etc. I have one TF that is now 400 pages! Also include a ‘History Page’ to document updates (but only since last examination by a NB – otherwise it could get silly).

Do searches on the Cove for templates etc to cover the items listed e.g. ‘Clinical Evaluation’.

I hope this helps.

Steve
 

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sagai

Quite Involved in Discussions
#4
Manuates used to publish here a nice comparison table having cross referencing for document naming convention between EU and US ...
 
F

FongPi

#6
Hello Sreenu927!
Thanks for the very helpful advice. So, what are you suggestions on how to write an addendum? I have a technical file which was written previously and there has been some minor changes to the product (software). Where I'm confused is, I've been told not to change any of the text in Part A, however, the information in Part A is now outdated because we have newer versions of supporting documents. So, would the addendum only contain tables of documents and references that have changed? It seems easiest to just re-write the whole thing.

I received one suggestion on updating Part A without changing the tech file, which was to include all the paragraphs and parts that changed, and put it together and call it an addendum. This approach however, seems very sloppy, and the addendum by itself would make no sense since it skips so many important parts of the tech file. Then again, I do realize that since it's an addendum it's meant to be used in conjunction with the original tech file.

So my question to the forum is, when the change is minor, and does not require re-certification by the Notified Bodies, then how are such changes captured? Would it be wrong to re-write most of the tech file, and then provide updated copies of the supporting documents in Part B?

Thanks again to everyone that is helping me with great advice!
 
F

FongPi

#7
Additionally have a look at this on the NB-MED site:

http://www.team-nb.org/index.php?option=com_docman&task=doc_download&gid=1205&Itemid=38&lang=en

I have submitted a number of technical files (Class IIa) to NBs and they have been ‘approved’, so I must be doing something right.

The attached is my version of the TF Contents; I use hyperlinks to navigate around as TFs can end up being large (pdf) documents, especially if when you include design history – which can include many stages of development/changes over the years i.e. contain internal reports etc. I have one TF that is now 400 pages! Also include a ‘History Page’ to document updates (but only since last examination by a NB – otherwise it could get silly).

Do searches on the Cove for templates etc to cover the items listed e.g. ‘Clinical Evaluation’.

I hope this helps.

Steve
So if there is a revision to a product (software) and then it's revised again, I wouldn't keep adding addendum after addendum, but rather take out the previous update and only include the most recent info? That makes sense.

How do you present this information when the text in say, the general description, is no longer accurate? Or say, if you have a table of applicable standards, is no longer up to date? I guess I'm having trouble figuring out how to present the updated information. I wish there was a sample that I could examine! Do you have any suggestions?

Thanks again!
 
S

SteveK

#8
So if there is a revision to a product (software) and then it's revised again, I wouldn't keep adding addendum after addendum, but rather take out the previous update and only include the most recent info? That makes sense.

How do you present this information when the text in say, the general description, is no longer accurate? Or say, if you have a table of applicable standards, is no longer up to date? I guess I'm having trouble figuring out how to present the updated information. I wish there was a sample that I could examine! Do you have any suggestions?

Thanks again!
I am constantly rewriting Technical Files – well updating relevant bits. All the developments e.g. to software, design etc can be added to the ‘Development’ section of the TF. My view is that it is a living document and is constantly evolving (not through addendums!). The cut off point is when it is first submitted to the NB for review – then issue as ‘1.0’ say, i.e. it is ‘frozen’. They may request changes which you conduct and resubmit as issue ‘1.1’ (with the changes summarised on a History Page as suggested in previous post). Again ‘freeze’ this version and keep on file, assuming it is accepted. As far as I’m concerned it then becomes a living, evolving document again as issue ‘1.2’ until it is reviewed by the NB again (which may be a long time in the future). Obviously retain previous copies of the various sections of the TF as various version/issue numbers as well e.g. Clinical Evaluation, ER, Risk Management etc as they individually evolve over time. It is potentially a lot of juggling but that is why you have a QMS.

Steve
 
F

FongPi

#9
This sounds like a plan! Is there an offical GHTF way to this, or is it up to the manufacturer?
 
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