PLATO Risk Management 14971Identify Interactions & Avoid Recalls
With PLATO Risk Management 14971 you can prove that your medical device offers more benefits than risks.
English
PLATO Risk Management 14971Identify complex interactions and avoid expensive recalls at an early stage
PLATO Risk Management 14971 focuses on standard-compliant risk analysis, in which the corresponding hazards and risks for the user are identified from the operating steps of a medical device. These are reduced to an acceptable level by means of risk-minimizing measures.
The implementation and effectiveness of the measures are monitored and documented using the risk control method.
PLATO Risk Management 14971 is database-driven and enables the connection to Design Control and Technical Risk Management, Knowledge and Template Management as well as Lessons Learned. The application is handled via the web browser – simple, convenient, available, networked.
The results are displayed at the push of a button in graphical (risk graph) and tabular form (list of risk dominating measures, extract from risk analysis, hazard list, etc.).
Why PLATO Risk Management 14971? Your benefits.
- The hazards and their additional information come from a centrally maintained hazard list.
- The medical and technical probabilities of occurrence are used to classify the risk.
- The severity of the damage can be converted to a value for the meaning B and passed on to the FMEA.
- The risk-minimizing measures are clearly per risk analysis.
- These measures are automatically transferred to the "risk control" method.
- They can be transferred as product requirements to advanced methods such as Design Control, FMEA, etc.
- For each risk analysis there are 3 risk graphs: 1 - empty, 2 - before, 3 - after with legend and hyperlink to the form.
| PLATO Design Control | PLATO Risk Management 14971 | PLATO Technical Risk Management | |
|---|---|---|---|
Traceability of Requirements incl. V+V | |||
Systems Analysis | |||
Requirements and Functional Analysis | |||
Specification (Design Input / Design Output) | |||
Risk Analysis | |||
Risk Graph | (RA) | (FMEA) | |
Risk Governance | |||
Risk Management Report | |||
Failure Analysis | |||
FMEA Form | |||
Measure Tracking, Newsletter | |||
Optional: Questionnaire (Appendix C) | () | ||
Recommended Additions for Your Comprehensive Development Process | |||
Action and Project Management | |||
Document Management for your Development Documents | |||
Visual Process Development | |||
Visual System Development | |||
Process Consulting | |||
Software and Method Trainings | |||
Project Support | |||
V+V: Design verification and design validation | RA: Risk analysis | FMEA: Failure mode and effects analysis | Optional: Can be supplied if required | |||
Ideas become products with PLATO e1ns - 100% web-based
Lessons Learned - Reuse of Knowledge and FMEA Templates
2:01 min
FMEA-MSR - Practical Guide
09:33 min
Product Development with PLATO e1ns | FollowMe
03:20 min
PLATO e1ns - Engineering is so simple
02:23 min
Get to know PLATO e1ns
03:30 min
FMEA connected | Create FMEAs in team work - worldwide and easy.
02:12 min
John The Quality Engineer gets to know e1ns.
01:30 min
PLATO e1ns at a Glance
10:58 min
Maik Teschner about the use of the PLATO Risk Management software SCIO™ at Nexperia Germany GmbH.
Holger Handelmann about the use of PLATO Risk Management Software SCIO™ at Lumileds Germany GmbH.
Jochen Bauhaus about the reasons for using the FMEA software from PLATO at Johann Borgers GmbH.
Gerhard Seifert about the reasons for using PLATO FMEA software at Tenneco GmbH.
Jürgen Heinzelmann about the use and the advantages of the template management system from PLATO.
Gary Baker, PhD, about the reasons for using the PLATO software at Johnson Matthey.
We are here to help. Get in touch.
You can call us directly. One of our representatives will be happy to help!
Leave us a message. We will respond immediately.
If you have a question or would like to outline your requirements in more detail, please fill out the form below.
We promise to review your submission and provide a response immediately.
You can also find PLATO on