PLATO Design ControlIntegration of risk management into development planning (design control)

The design control process furnishes proof that your medical device is safe to use and meets the user requirements of the market. It is intended to ensure that the development process becomes more transparent for all parties involved (e.g. production, management).

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 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.

Why PLATO Design Control? Your benefits.

  • Integration of risk management into the development process promotes acceptance within the development team.
  • Fast additions/changes through central management of data and analyses.
  • Security through central action monitoring.
  • Effective knowledge management by graphical evaluations and database analyses.
  • Shorter approval times thanks to uniform and up-to-date product files at the touch of a button.

To top

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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