Safety and reliability as top priority.

Medical technology companies face the challenge of meeting planned costs and time-to-market as well as integrating regulatory activities into the development process. Keeping an eye on patient safety is a top priority. In order to manufacture medical devices of consistently high quality, the documentation must be comprehensible and complete, the manufacturing processes reproducible, traceable and process-reliable, and the quality of the materials used must be consistent.

Medical devices are becoming more and more complex and the recall campaigns of recent years show that the "technical risk" factor is gaining considerably in importance. For this reason, we are integrating technical risk management into PLATO e1ns, which has been adapted for the medical device industry, in addition to compliance with standards. "PLATO e1ns - Risk Management DIN EN ISO 14971" provides the development accompanying methods for risk management in a common data concept (database). All project participants can access and edit the current data at any time. e1ns links the methods and data in such a way that redundant data and time-consuming data maintenance are a matter of the past.

PLATO e1ns - Engineering data for technical documentation at the touch of a button

Close the gap between standards compliance and technical risk analysis

  • PLATO e1ns masters complexity

  • Consistency of risk requirements for review and risk control

  • No document dependencies, changes immediately available

Create acceptance in your development team

  • By integrating risk management into the development process
  • Quick addition/change through central management of data and analyses
  • Standard conformity through uniform methods
  • Shortened approval procedures through uniform layout for printout and approval circulation
  • Effective knowledge management through evaluations via database queries
  • Security through central monitoring of measures

PLATO e1ns guarantees compliance with standards

  • Selection of available methods for analysis and presentation of development-related data
  • Consistency and actuality of all data

PLATO e1ns ensures transparency

  • Knowledge management
  • Current status of tests, actions and risks available at all times (traceability)

Since the correct application of ISO 14971 is a prerequisite for other standards such as IEC 62304, IEC 62366 and IEC 60601-1, the importance of ISO 14971 and therefore of risk management activities is paramount. PLATO e1ns provides risk management data at the push of a button, which is attached directly to the approval file of the medical devices.

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Document management for manufacturers of pharmaceutical and medical products

Documentation plays an important role in the GxP-regulated areas. Creating, releasing, providing and searching all kinds of organizational documents - all this is very easy with PLATO XERI™. Live search, tagging, storable search filters make it easier for your employees to get the right document. Companies can customize the document management software XERI™ by creating graphical entry pages.

Your advantages at a glance

  • Low effort for changes and maintenance of the QM system
  • Improved process-oriented information search
  • Linking to other applicable documents (e.g. work instructions, forms)
  • Automated distribution to employees
  • Ensuring that documents are up-to-date and traceable via audit trails
  • 100% web-based
  • Consequent and consistent linking of the activities, information and organizational units in the process model.
  • Electronic signature according to FDA 21 CFR Part 11
  • Interactive process graphics
  • Extensive search options, such as live search, tagging, storable search filters

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FMEA connected - Integrated into methods and development processes through state-of-the-art web technology

To this day, medical technology is, besides the automotive industry, the industry with the strongest awareness of FMEA and risk management and causes that companies, from small and medium-sized businesses to corporations, look to the experiences there in many areas.

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