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.
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 | ✔ | ✔ |
| FEATURE | CLOUD HOSTED | ON PREMISE |
|---|---|---|
| Figure 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 & Release workflow |
✔ | ✔ |
| Audit Trail & Version history |
✔ | ✔ |
| Validation acc. ISO 13485 |
The environment is validated by the manufacturer |
Prepared validation forms are made available at |
| Optional services |
30 days free trial period, application training |
30 days free trial period, installation support, application training, validation service |
| Technical Support |
✔ | ✔ |
