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 ControlDesign Controland 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.

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PLATO Design ControlPLATO Risk Management 14971PLATO 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)
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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

PLATO e1ns - Beyond FMEA

2:13 min

PLATO e1ns - Engineering is so simple

2:23 min

The development of the FollowMe with PLATO e1ns

3:20 min

FMEA connected - Create FMEAs in team work - worldwide and easy.

2:13 min

Marcus Schorn, CTO of PLATO AG, in the interview at the Control 2017

1:38 min

Maik Teschner, Nexperia Germany GmbH

Maik Teschner about the use of the PLATO Risk Management software SCIO™ at Nexperia Germany GmbH.

Holger Handelmann, Lumileds Germany GmbH

Holger Handelmann about the use of PLATO Risk Management Software SCIO™ at Lumileds Germany GmbH.

Jochen Bauhaus, Johann Borgers GmbH

Jochen Bauhaus about the reasons for using the FMEA software from PLATO at Johann Borgers GmbH.

Gerhard Seifert, Tenneco GmbH

Gerhard Seifert about the reasons for using PLATO FMEA software at Tenneco GmbH.

Jürgen Heinzelmann, Mahle Behr GmbH & Co. KG

Jürgen Heinzelmann about the use and the advantages of the template management system from PLATO.

Gary Baker, PhD, Johnson Matthey

Gary Baker, PhD, about the reasons for using the PLATO software at Johnson Matthey.

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