
Safety and reliability as top priority.
The basis for the development of medical devices is good risk management. It must meet required standards, get technical risks under control at an early stage and provide transparency.

In the product development of medical devices are 4 quality management processes in focus:
PLATO e1ns offers a solution package that ensures consistency from requirements to risks to verification and validation. Due to the model-based data model of PLATO e1ns, redundant data or time-consuming data maintenance after changes are a thing of the past.
PLATO e1ns with its extensible method kit also offers the possibility to implement further standards (ISO 60601, ISO 62366 etc.).
PLATO XERI™ Document Management guarantees the systematic and standardized control of documents in your organization.
From Requirements Management to the complete integration of Risk Management into the product development - PLATO has the solution for your development process of medical devices.
PLATO Design Control: Keep track on all your requirements - from the first idea to the final product.
PLATO Risk Management 14971: Prove that your medical device offers more benefits than risks.
PLATO Technical Risk Management: Identify complex interactions and avoid expensive product recalls at an early stage in the product development process.
PLATO e1ns provides all these methods and data on one data basis so that redundant data or complex data maintenance are now things of the past. e1ns also offers an expandable method toolbox which can be used to implement further standards (ISO 60601, ISO 62366, ...).
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 |
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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.
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