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.

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

FEATURE CLOUD HOSTED ON PREMISE
Illustration of standard requirements MDR 2017/745
IVDR2017/746
MDR 2017/745
IVDR 2017/746
Document management
Traceability
Generation of Technical Documentation file (incl. structure)
Team collaboration options
Versioning and release workflow
Audit trail and version history
Validation acc. ISO 13485 The environment is validated by the manufacturer Prepared validation forms are provided
Optional services 30-day free trial period, application training 30-day free trial period, installation support, application training, validation service
Technical support

Other modules that might interest you.

Risk Manager

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

Device Validation Manager

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

Requirements Engineer

Manage all requirements (MDR, IVDR, general product requirements, …) in a clear and structured way in one central location.

Svenja Winkler
CEO

How to contact us

How would you like to work in the 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.