Themis Ultimate Pack [Hosted / Software as a Service]

€223.72 €188.00
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A new approach to technical documentation

Efficient and standard-compliant

Your validated solution for documentation processes of medical devices and in vitro diagnostics – Digitize linked processes and sustainably reduce documentation efforts while minimizing redundant data.

As regulatory requirements continue to rise, the world of work is becoming increasingly volatile. Issues such as collaboration, growing teams and cross-site working are now commonplace in the world of medical device and in vitro diagnostics manufacturers.

How can you keep efforts and costs as low as possible at the same time? With BAYOOSOFT Themis, the validated and standard-compliant solution for increasing regulatory productivity.

Here’s how it works: Processes are digitized and accelerated through the central management and linking of individual information units. Not only individual tasks, but entire process chains are thus optimized. As a result, the use of resources and error rates are far lower than with manual processing. As a result, you could sustainably reduce operational efforts, e.g. when updating existing files. At the same time, you increase the acceptance of the developed files by your notified body.

Themis Ultimate includes the Themis Documentation Guide as well as all available Themis-extensions for the MedTech sector and is therefore ideal for all overarching functions within your organisation.

The Themis Ultimate Pack consists of

  • Documentation Guide
    • Browser-based guideline for creating technical documentation.
  • Requirements Pack
    • Requirements Engineering:
      This requirements analysis supports you in documenting the requirements comprehensively and comprehensibly throughout the product life cycle.
    • Essentials Principles Checklist:
      With Essential Principles Checklist, you can record your requirements for various target countries using an interactive checklist.

Teamwork

Collaboration reimagined

Thanks to multi-user capabilities, team members are able to create content and deliverables in parallel in the same file and are guided through the process in a structured manner. By tagging and assigning pending and processed tasks, team dashboards, notifications as well as chats and comments, you can easily and efficiently share information within your team – even across sites.


Digitization

One central data pool

In a clearly structured environment, all relevant information is gathered and dynamically linked with each other in a fine-granular manner. The knowledgebase also generates cross-project synergies and enables you to use the generated know-how throughout the organization. The creation of a knowledge platform as well as structured templates facilitates the efficient and secure performance of documentation processes. 


Compliance

In conformity with MDR & IVDR

The approval of your product by the Notified Body will be determined by its conformity with the applicable directives, norms and standards. The software solution generates comprehensive and compliant Technical Documentation based on your data and guides your team efficiently through all the necessary processes – even for inexperienced colleagues.

* The product "Payment method authorisation fee" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.

For a download version (installation on premise), please contact our sales department: [email protected]

 

Cloud Hosted / Software as a Service

Modules included in the package

All modules of the following packages/extensions:

-    Documentation Guide

-    Requirements Pack

      o   Requirements Engineering
      o   Essentials Principles Checklist

Document Management 

✓ 

Traceability 

✓ 

Generation of requirements and specification documents for each target country

Team Collaboration Capabilities 

✓ 

Versioning & Approval Workflow

✓ 

Audit Trail & Version History

✓ 

Validated according to ISO 13485 

Environment is validated by manufacturer 

Technical Support

Optional Services

30 days free trial period*
User Training 

* The product "Payment method authorisation fee" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.

Themis Ultimate is licensed in the form of named user licenses, which can be assigned directly in the software solution by the system administrator after purchase. The minimum purchase quantity is three named users.

Licenses can be purchased in the form of a subscription model with a monthly or annual term. The first month is a free trial period.

* The product "Payment method authorisation fee" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.