Regulatory Open Forum

Dear Community,

i would like to ask for your recommendations and your experience. Iam in the middle of evaluating, how to optimize our Instruction for use structure. Thus i question also our current in use software: "InDesign".

I have started a research, but would like t include your recommendations and experience in my Choice.
Can you recommend a Software to create an instruction for use, what are your experiences with the software you use/recommend?

I think important criteria are:
- can it format text easily and combine it with grafics?
- can it format to print, also for external printing?
- can it use standard "text blocks", that makes it more effective to translate multiple IFUs?
- is it easy to use?
- cost
- optional: does it support with kind of a standard structure to Comply with MDR, MDSAP?

Thanks in avdvance for your support
Best regards
Lutz



------------------------------
Lutz Babilon
Director QM/RA
Freiburg im Breisgau
Germany
------------------------------

Dear Lutz

There are so many options for authoring, publishing, and text management software... The most usable for an organization will depend on things like how much text there is to manage, how many people are involved in editing the text, how the review process is managed.  I've seen an assortment used at different size companies, each with pluses and minuses.

With something like Microsoft Word, a simple document is easy to edit and share. A larger document with complex formatting, lots of graphics, and redlining can become unstable.

Tools like FrameMaker and InDesign are much more robust for formatting, but they're more expensive and have a steeper learning curve.

If you have a lot of text to manage, you might benefit from a DITA (Darwin Information Typing Architecture) system. They're more expensive up front, and a project to initialize, but ideal for handling standard text blocks.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 08-Sep-2022 02:32
From: Lutz Babilon
Subject: Software for creating an Instruction for use

Dear Community,

i would like to ask for your recommendations and your experience. Iam in the middle of evaluating, how to optimize our Instruction for use structure. Thus i question also our current in use software: "InDesign".

I have started a research, but would like t include your recommendations and experience in my Choice.
Can you recommend a Software to create an instruction for use, what are your experiences with the software you use/recommend?

I think important criteria are:
- can it format text easily and combine it with grafics?
- can it format to print, also for external printing?
- can it use standard "text blocks", that makes it more effective to translate multiple IFUs?
- is it easy to use?
- cost
- optional: does it support with kind of a standard structure to Comply with MDR, MDSAP?

Thanks in avdvance for your support
Best regards
Lutz



------------------------------
Lutz Babilon
Director QM/RA
Freiburg im Breisgau
Germany
------------------------------

Hello Lutz,

I agree with Anne in the fact there are so many graphic design applications which could be used from simply Word to a more sophisticated programme like Page Maker.  In my experience this is usually the Marketing or Labelling group which defines or uses the application, with input from Regulatory Affairs concerning the content.  As there is no formal structure or exact content of labels and Instructions for Use (IFUs) for medical devices, this is left up to each organisation.  Also there are more and more companies using electronic IFUs (eIFU) finding a platform which can publish well electronically and hard copy is usually also needed.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 10-Sep-2022 10:38
From: Anne LeBlanc
Subject: Software for creating an Instruction for use

Dear Lutz

There are so many options for authoring, publishing, and text management software... The most usable for an organization will depend on things like how much text there is to manage, how many people are involved in editing the text, how the review process is managed.  I've seen an assortment used at different size companies, each with pluses and minuses.

With something like Microsoft Word, a simple document is easy to edit and share. A larger document with complex formatting, lots of graphics, and redlining can become unstable.

Tools like FrameMaker and InDesign are much more robust for formatting, but they're more expensive and have a steeper learning curve.

If you have a lot of text to manage, you might benefit from a DITA (Darwin Information Typing Architecture) system. They're more expensive up front, and a project to initialize, but ideal for handling standard text blocks.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 08-Sep-2022 02:32
From: Lutz Babilon
Subject: Software for creating an Instruction for use

Dear Community,

i would like to ask for your recommendations and your experience. Iam in the middle of evaluating, how to optimize our Instruction for use structure. Thus i question also our current in use software: "InDesign".

I have started a research, but would like t include your recommendations and experience in my Choice.
Can you recommend a Software to create an instruction for use, what are your experiences with the software you use/recommend?

I think important criteria are:
- can it format text easily and combine it with grafics?
- can it format to print, also for external printing?
- can it use standard "text blocks", that makes it more effective to translate multiple IFUs?
- is it easy to use?
- cost
- optional: does it support with kind of a standard structure to Comply with MDR, MDSAP?

Thanks in avdvance for your support
Best regards
Lutz



------------------------------
Lutz Babilon
Director QM/RA
Freiburg im Breisgau
Germany
------------------------------

Thank you Anne and Richard for your valueable Feedback. This helps me goin on. I probably will downsize to Word and have atry - keep it simply is sometimes the best. Best regards Lutz

------------------------------
Lutz Babilon
Director QM/RA Black Forest Medical Group
Freiburg im Breisgau
Germany
------------------------------

Original Message:
Sent: 11-Sep-2022 03:10
From: Richard Vincins
Subject: Software for creating an Instruction for use

Hello Lutz,

I agree with Anne in the fact there are so many graphic design applications which could be used from simply Word to a more sophisticated programme like Page Maker.  In my experience this is usually the Marketing or Labelling group which defines or uses the application, with input from Regulatory Affairs concerning the content.  As there is no formal structure or exact content of labels and Instructions for Use (IFUs) for medical devices, this is left up to each organisation.  Also there are more and more companies using electronic IFUs (eIFU) finding a platform which can publish well electronically and hard copy is usually also needed.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 10-Sep-2022 10:38
From: Anne LeBlanc
Subject: Software for creating an Instruction for use

Dear Lutz

There are so many options for authoring, publishing, and text management software... The most usable for an organization will depend on things like how much text there is to manage, how many people are involved in editing the text, how the review process is managed.  I've seen an assortment used at different size companies, each with pluses and minuses.

With something like Microsoft Word, a simple document is easy to edit and share. A larger document with complex formatting, lots of graphics, and redlining can become unstable.

Tools like FrameMaker and InDesign are much more robust for formatting, but they're more expensive and have a steeper learning curve.

If you have a lot of text to manage, you might benefit from a DITA (Darwin Information Typing Architecture) system. They're more expensive up front, and a project to initialize, but ideal for handling standard text blocks.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 08-Sep-2022 02:32
From: Lutz Babilon
Subject: Software for creating an Instruction for use

Dear Community,

i would like to ask for your recommendations and your experience. Iam in the middle of evaluating, how to optimize our Instruction for use structure. Thus i question also our current in use software: "InDesign".

I have started a research, but would like t include your recommendations and experience in my Choice.
Can you recommend a Software to create an instruction for use, what are your experiences with the software you use/recommend?

I think important criteria are:
- can it format text easily and combine it with grafics?
- can it format to print, also for external printing?
- can it use standard "text blocks", that makes it more effective to translate multiple IFUs?
- is it easy to use?
- cost
- optional: does it support with kind of a standard structure to Comply with MDR, MDSAP?

Thanks in avdvance for your support
Best regards
Lutz



------------------------------
Lutz Babilon
Director QM/RA
Freiburg im Breisgau
Germany
------------------------------