What is meddevo eTD?

meddevo eTD replaces document-driven technical documentation with a structured, data-based regulatory model - built for medical device and IVD manufacturers who need to manage products, product groups, and certificates across one or several regulatory frameworks (such as EU-MDR, EU-IVDR, or FDA).

The problem meddevo eTD solves

Traditionally, technical documentations are maintained as a collection of Word and PDF files spread across folders. The same information - a patient population, a performance parameter, a risk statement - often has to be re-entered manually in several different documents. Whenever one product changes, every document referencing it has to be checked and updated by hand. Over time, this leads to redundant, inconsistent, and hard-to-trace documentation.

meddevo eTD addresses this by separating content from documents:

Regulatory information is entered once, in the right place, and stored in structured collections.
Documents are then generated automatically from that stored content.
If the underlying content changes, eTD flags every document that is affected, so nothing goes out of date unnoticed.

How meddevo eTD is structured

meddevo eTD organizes your product portfolio in three hierarchical levels:

Level	Purpose
Technical Documentation (eTD)	The top level. Groups together the product groups for which a shared certificate is pursued.
Product Group (PG)	Used for product families or groups whose characteristics are largely the same and can be managed together.
Product (P)	The individual, sellable product.

You are free to use all three levels, or only one or two, depending on how your portfolio is organized. The guiding principle is: keep information as high up in the hierarchy as it remains valid, and only push it down to a lower level when it genuinely differs from product to product. This avoids duplicate entries and keeps future updates fast - a change made once at the Product Group level automatically applies to every Product beneath it.

From content to compliant documents

Once content is entered into meddevo eTD's collections, it goes through two consecutive steps on its way to a compliant document:

Document generation - Documents are generated automatically from the stored content, combining information from a collection with all of its connected collections.
Virtual Folders - Generated documents are automatically placed into a predefined folder structure that follows normative requirements, such as EU-MDR or FDA structures. This structure also drives Document Monitoring, which continuously checks whether every required document exists and is still up to date.

Every change to underlying content is recorded in the Audit Trail, ensuring traceability from the first data point all the way to a finalized submission.

What eTD is - and isn't

eTD is a specialized tool for managing the technical documentation of medical devices: organizing, automating, and exporting regulatory data and documents in a structured, compliant way. It is not a general process-management system. eTD does not run or track your actual risk management process, design and development process, clinical evaluation activities, PMS process, or QM processes (such as CAPA or complaint handling) - it manages and stores the documents and data that result from those processes, but the processes themselves take place outside of eTD.

Where to go next