DE 
Themis Medical Risk Pack [Hosted / Software as a Service]
€79.73
€67.00
In stock
Product.Nr.
BYS-THMED-RSP-H
Risk management for medical devices and in-vitro diagnostics
Medical devices that are applied directly to or inside the human body pose specific risks that require a particularly high level of protection. When using the product, the residual risk must be weighed against the benefits. On an international level, a unified risk management approach for medical devices and in-vitro diagnostics is therefore required.
The internationally recognized standard ISO 14971 describes a procedure for identifying, assessing, evaluating, and controlling hazards associated with medical devices and their accessories. It also defines how the effectiveness of the implemented measures should be monitored.
BAYOOSOFT Themis' Risk Pack provides you with a clearly structured environment to efficiently capture all relevant information, store it centrally and securely, and dynamically link it in a detailed manner.
Essentials Principals Checklist: Grundlegende Sicherheits- und Leistungsanforderungen
The Risk Pack includes the following modules:
- Risk Management Plan
- Risk Analysis, Assessment, and Control
- Overall Residual Risk
- Risk Management Review
- Activities in Subsequent Manufacturing Phases
Teamwork
Collaboration Rethought
Thanks to multi-user capability, colleagues can simultaneously capture content and results in the same document and are guided through the process in a structured manner. The use of task labelling and assignment (for open and processed tasks), team dashboards, notifications, as well as chats and comments, enables easy and fast communication within the team – even across multiple locations.
Digitization
A Centralized Data Pool
In a clearly structured environment, all relevant information is captured and dynamically linked in fine detail. The knowledge database creates cross-project synergies and promotes company-wide utilization of the developed know-how. The design of the knowledge platform and structured templates enable efficient and secure execution of documentation processes.
Compliance
In Conformity to ISO 14971
The approval of your product by notified bodies largely depends on compliance with the required guidelines, standards, and regulations.
Our software solution creates complete and compliant technical documentation from your data and efficiently guides your team through all necessary processes, even if team members have no prior experience.
* The product "Authorization Fee for Payment Method" will be added to your shopping cart, with a fee of €0.50 (excluding VAT).
For the downloadable version (on-premise installation), please contact our sales department at: [email protected].
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Cloud hosted / Software as a Service |
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Modules included in the package |
Risk management according to ISO 14971:
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Document Management |
✓ |
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Traceability |
✓ |
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Generation of Documentation |
✓ |
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Team Collaboration Capabilities |
✓ |
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Versioning & Approval Workflow |
✓ |
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Audit Trail & Version History |
✓ |
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Validated according to ISO 13485 |
Environment is validated by manufacturer |
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Technical Support |
✓ |
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Optional Services |
30 days free trial period* |
* The product "Authorization Fee for Payment Method" will be added to your shopping cart, with a fee of €0.50 (excluding VAT).
The licensing of the Themis Medical Risk Pack is done in the form of Named-User licenses, which can be assigned directly by the system administration in the software solution after purchase. The minimum order quantity is three Named-User licenses.
Licenses are available on a subscription basis with monthly or annual terms, with the first month offered as a free trial period.
* The product "Authorization Fee for Payment Method" will be added to your shopping cart, with a fee of €0.50 (excluding VAT).