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.
| Feature | Cloud hosted | On premise |
|---|---|---|
| Illustration of standard requirements | MDR 2017/745 IVDR 2017/746 | MDR 2017/745 IVDR 2017/746 |
| Document management | ✔ | ✔ |
| Traceability | ✔ | ✔ |
| Generation of Technical Documentation File (incl. structure) | ✔ | ✔ |
| Team collaboration opportunities | ✔ | ✔ |
| Versioning & release workflow | ✔ | ✔ |
| Audit Trail & Version History | ✔ | ✔ |
| Validation according to ISO 13485 | The environment is validated by the manufacturer. | Prepared validation forms are provided. |
| Optional services | 30 days free trial period, application training | 30 days free trial period, installation support, application training, validation service |
| Technical support | ✔ | ✔ |
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.
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.
Svenja Winkler
CEO
[email protected]
Franziska Weiß
Head of Sales
[email protected]
