Themis Requirements Pack [Hosted / Software as a Service]

€79.73 €67.00
In stock
Product.Nr.
BYS-TH-RP-H
Subscription details

Your requirements efficiently

Requirements analysis is an indispensable part of the efficient and user-friendly development of complex medical device systems. It is particularly important for interrelated product and system concepts and development based on division of labour. By recording, specifying and validating the requirements, potential sources of error can be identified at an early stage and proactively addressed. The results are improved product quality, shorter development times and ultimately cost savings.

This requirements analysis supports you in documenting the requirements comprehensively and comprehensibly throughout the product life cycle.

Essentials Principals Checklist: Essential safety and performance requirements

In order to be able to place your medical device or in-vitro diagnostic medical device on the market, in addition to the fulfilment of product-specific requirements, conformity with the essential safety and performance requirements or essential principles of the target countries in particular must be demonstrated. The "Essential Principles Checklist" module contained in the Requirements Pack offers you an interactive checklist with which you only have to answer the relevant questions for the product. This allows you to fulfil the same requirements for different target countries only once for your product but generate the necessary reports individually for each country. The following areas of application are currently available:

    ✓   European Union (medical devices and in-vitro diagnostics) / MDR & IVDR

    ✓   MDSAP countries

  • Australia
  • Canada

 


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 "Authorization Fee for Payment Method" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.

 

 

Cloud hosted 

On premise

Modules included in the package

Requirements Engineering

Essential Principles Checklist

Requirements Engineering

Essential Principles Checklist

Document Management 

✓ 

✓ 

Traceability 

✓ 

✓ 

Generation of Technical Documentation Files including folder structure

✓ 

✓ 

Team Collaboration Capabilities 

✓ 

✓ 

Versioning & Approval Workflow

✓ 

✓ 

Audit Trail & Version History

✓ 

✓ 

Validated according to ISO 13485 

Environment is validated by manufacturer 

Prepared validation document forms will be provided

Technical Support

Optional Services

30 days free trial period*
User Training 

30 days free trial period*
User Training 

* The product "Authorization Fee for Payment Method" 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.