GeMA is an advanced AI tool designed that helps generate content and assess impacts on your device. It is included as standard with all Tento+ modules and provides huge benefit in managing your compliance.

Where can I find GeMA?

You’ll see a little spinning purple icon across device. This is GeMA. Click on that button and GeMA will appear on the side offering you relevant options to be used. Remember, GeMA is suggesting useful content for you, you still need to review it and make sure you are happy it reflects your device well.

What GeMA does do?

1. Requirement Generation: GeMA uses its natural language processing capabilities to assist in the creation of design requirements. It helps you define and articulate functionality, safety considerations, and performance metrics.
2. Test Plan Development: Crafting comprehensive test plans can be a time-consuming task. GeMA simplifies this by generating test plans based on your design specifications.
3. Design Traceability Assistance: Writing design traceability documents in accordance with medical device standards can be complex. GeMA assists you in generating well-structured, standardized design traceability through the creation of functions and units from requirement ensuring transparency and traceability.
4. Anomaly Assessment: GeMA is able to assess and recommend which anomalies you might want to look at first, based on the impact on the test records and requirements.

What GeMA doesn’t do?

1. Acceptance criteria: Whilst GeMA can generate requirements, we leave it to you decide the acceptance criteria and measurable details of each requirement, as this should be based on clinical and safety input.
2. Detailed test protocols: GeMA can understand what any device does, just about, but it won’t know the details of its operation and testing steps. The test plan generation, described above, gives an overview of areas you should considering testing, how you perform that test is up to you.
3. Source mapping: Whilst GeMA can create a decomposition of a system component, GeMA doesn’t have access to your design files (such as software source or mechanical drawings). As such, we leave it to you to map those files to the component units.
4. Safety Reviews: Whilst GeMA can access anomalies based on how many requirements it affects, you will need to design the safety implication of any anomaly which may change the priority of defect fixing.