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.

PLATO Solutions for Medical Technology

In the product development of medical devices are 4 quality management processes in focus:

  • Design Control
  • Risk management
  • Document management

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.

PLATO e1ns - Solutions for Medical DevicesRisk Management in the Development Process.

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.

Integration of Risk Management according to DIN EN ISO 14971 in the Development Process

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 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)
()

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

Your benefits.
  • The integration of Risk Management in the development process promotes acceptance within the development team.
  • Quick additions / changes through central data maintenance and analyses.
  • Safety through centralized action monitoring.
  • Effective knowledge management through visual evaluations and data base analyses.
  • Shortened approval times through consistent and current product data at the push of a button.
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, 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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