How to set up meddevo for your portfolio
By now you have probably seen the general structure of meddevo:
meddevo is structured via various collections containing different contentfields, the content of which is displayed and managed in entry views and in the end get put into documents.
While meddevo is a pre-configured system that offers many solutions for different frameworks and different areas of regulatory affairs, depending on your specific portfolio, your specific products or simply on the historically grown customs of your company, not everything will fit perfectly from the first second on.
This article is a guide for you on how to best add information into meddevo.
What type of Data is it? | Example | Where to place my data? | Justification |
---|---|---|---|
Different Information reused for many different products in many different documents | Patient Population โAdultโ aged 18 to 99 | Collection | Save this information in a collection, as many different products might use it in many different documents. |
Information for one product always displayed together - even if its with different headers, tables etc. | Detailed step-by-step instructions how to use the product. | One Form Field | Save this information, structured and formatted as needed, with the product. |
Information for one product displayed together but possibly you also want to display them separately | The different performance parameters. | Several Form Fields | Often you will provide all this information together, but specific risks or PMS findings might relate to only one, making it necessary to display the information separately from one another. |
A static information that is always the same, no matter what product the document is for. | A general disclaimer in the IFU that all serious incidents shall be reported. | Document Template | This information applies to all products and will be relevant for each IFU generated from this template. |
In general, we advice against putting any information directly into documents. In order for the system to be able to track changes and send notifications about necessary updates, information should be tracked in collections whenever possible. Automatic updates to documents, that have manually added information, can result in errors.