
PLATO Design ControlTransparent Development Processes for All Parties Involved
With PLATO Design Control you have all requirements - from the first idea to the end of marketing - in view.

The Design Control Process is designed to improve the safety and efficiency of medical device development. PLATO Design Control focuses on the traceability of user needs from design input to design validation.
PLATO Design Control and System Analysis is database-driven and enables knowledge and template management as well as lessons learned process. The application is handled via the web browser - simple, convenient, available, networked. Results - from user requirements and risk-minimizing measures to product function and specification - can be displayed and output graphically in block diagrams, navigable network structures or tables at the touch of a button.
Thus, problems and interdependencies can be identified more quickly and resolved in a targeted manner. PLATO Design Control not only supports new developments, but also changes and further developments of medical devices.
The application of Design Control is required by the FDA for the product development of medical devices and more precisely defined in FDA 21 CFR 820.30. In Europe, this term is almost identically dealt with in DIN EN ISO 13485 in Section 7.3 Design and Development.
With PLATO Design Control, you can achieve this through a traceable and consistent networking of methods, data and documents from risk management to technical product development.
The Design Control process describes the process of product development and provides the specifications for technical product development. The system analysis describes the product to be developed theoretically through the steps of requirements definition, functional analysis, logical architecture design and component specification and specifies the resulting product models.
PLATO Design Control | PLATO Risk Management 14971 | PLATO Technical Risk Management | |
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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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09:33 min
03:20 min
02:23 min
03:30 min
02:12 min
01:30 min
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.
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