How does a DAM help ensure compliance with the MDR?

TESSA records every change to an asset in the activity log — who changed, approved or archived what, and when, exportable as CSV for your auditors. Through the approval on the asset and rights from groups and roles you make sure only reviewed materials go into circulation; an outdated version you lock, and partners can no longer retrieve it.

How can medical device manufacturers efficiently provide product data to their distributors?

Instead of sending data manually, we recommend using a centralized self-service portal. With TESSA BrandHub, partners such as dental suppliers can independently access the latest approved images and documents, which streamlines processes for both sides and ensures brand consistency.

How does the information from the IFU get into the product database?

When an IFU (Instructions for Use) is uploaded, TESSA automatically identifies the associated metadata based on the file name and fills in the corresponding fields. This file is immediately transferred to the PIM system, where it is permanently linked to the respective product. The OSKAR Middleware handles the deployment to the portal, ensuring that the latest version of the instructions for use is immediately available to users without any manual steps.

What do IFU, eIFU and UDI mean?

IFU stands for Instructions for Use, the manual of a medical device; eIFU is its electronic provision. UDI is the Unique Device Identification, the code by which a device can be identified worldwide. In TESSA you hold UDI, approved markets and the validity of the instructions as your own fields on the document, and filter by them.

What part does a DAM play in MDR compliance?

The MDR obliges manufacturers to show at any time which documentation was valid, and in circulation, at which point. TESSA keeps an activity log for that: who replaced, approved or archived which file, and when — exportable as CSV or OCSF for your auditors. MDR compliance itself remains yours; TESSA supplies the evidence for it.

How do I make sure a withdrawn instruction for use can no longer be retrieved?

Nothing leaves the system without approval. A withdrawn version you lock, and partners can reach it neither through the portal nor through a link — it stays archived for the record. Links you handed to distributors or notified bodies expire on their own anyway; in the link manager you revoke them earlier with one click.

Can we run TESSA in our own data centre?

Yes, TESSA is available as an on-premises installation, with all data staying on your own servers. In the hosted variant the data sits in Germany. Either way you bundle rights through groups and roles, and sign-in can be tied to your existing user directory.

How many file formats does a DAM in medical technology have to cover?

In practice, product photos are joined mainly by PDFs for data sheets and instructions, Office documents for training material, and videos demonstrating use. TESSA manages those formats alike and gives every asset the fields your quality management needs.

Digital Asset Management for Medical Technology

Technical documentation for medical devices

We help medical device manufacturers and distributors manage complex product portfolios consistently, in compliance with legal requirements, and through automated processes across all channels.

MDR documentation
PIM/ERP integration
Dealer portal
Shorter time to market
Brand consistency
Image conversion

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Here's how TESSA supports you and your team in the medical technology sector

Challenge

Technical documentation for medical devices, such as IFUs (Instructions for Use) or data sheets, is constantly updated and stored in various systems. Manually assigning and distributing these files to online stores or distributors is prone to errors and results in outdated versions remaining in circulation.

Your solution with TESSA

Seamlessly connected systems

By directly connecting TESSA DAM to your PIM system, information from the data sheets and IFUs is imported and synchronized with the product images. So the current, approved version is the one available everywhere — older ones drop out of the recipients' view.

Challenge

Product images and related data (eIFU, data sheets, etc.) need to be shared with specialty retailers, distributors, or international locations.

Your solution with TESSA

Self-service for medtech sales

With TESSA BrandHub, you provide medical technology resellers with controlled access to approved marketing assets. Your partners can download images and the associated information directly in the appropriate target format themselves, without requiring manual intervention on your part.

Challenge

Strict MDR requirements mandate that marketing teams and partners access only currently approved materials. Outdated documents in circulation or missing MDR certificates can quickly lead to liability risks for medical device manufacturers.

Your solution with TESSA

Role & rights management

Rights are bundled through groups and roles: every team and every partner sees exactly the content they are cleared for. UDI, approved markets and the validity of the instructions for use live as your own fields on the document — and for an audit you export the activity log as CSV.

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Additional features of TESSA for medical technology

AI features
Cut-outs and output formats as a preset: every product shot comes out the same. TESSA labels generated scenes as AI-edited.
Intelligent search
Find the digital assets you need for medical devices easily, intuitively, and quickly.
Saved views
The view your graphics team needs again and again you save as a workspace: folders, filters and columns stay the way they were.
Custom data fields for product records
UDI, approved markets, validity of the instructions for use: model the fields your medical devices actually need — and search by them.
Complete activity log
Who replaced, approved or archived which file, and when? TESSA logs every change — the basis for evidence in an audit.
File links with an expiry date
Hand documents to notified bodies, distributors or clinics for a limited time, optionally password-protected. No account needed.