Documentation Guide

Which documents have to be submitted to the Notified Body for approval? What is the current status of the information supplied? Who is currently working on it and what do you still have to release?

You ask yourself questions like these every day? Gain transparency and get an overview with the Themis Documentation Guide.

BAYOOSOFT Themis Module und Funktionen

As regulatory requirements continue to rise, the world of work is becoming increasingly volatile. Topics such as collaboration, growing teams and working across locations are now commonplace in the world of medical device manufacturers.

This is exactly why BAYOOSOFT Themis is redesigning the way technical documentation is done – holistically, innovatively, individually and globally.

An overview: All features and options

FeatureCloud hostedOn premise
Illustration of standard requirementsMDR 2017/745
IVDR 2017/746
MDR 2017/745
IVDR 2017/746
Document management
Generation of Technical Documentation File (incl. structure)
Team collaboration opportunities
Versioning & release workflow
Audit Trail & Version History
Validation according to ISO 13485The environment is validated by the manufacturer.Prepared validation forms are provided.
Optional services30 days free trial period, application training
30 days free trial period, installation support, application training, validation service
Technical support

Further modules that might interest you

Requirements Manager

Device Validation Manager

Risk Manager

Manage all requirements (MDR, IVDR, general product requirements, …) clearly, structured and centrally.

Your fast track to release your medical or IVD product: plan and document all tests centrally.

Risk management in accordance with ISO 14971: Whether PHA or FMEA – you are guided in a structured manner through all work steps.

How would you like to work in future?

Be part of it and shape the Tech Doc of tomorrow with us. Send us a short message and our team will take care of your request immediately.


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