In medical technology, technical risk management is crucial to ensure the safety and effectiveness of medical devices and products. It includes the process of identifying, analyzing, assessing and controlling risks. This approach makes it possible to identify and respond to possible disruptions, failures or problems early on, minimizing the likelihood of negative impacts.

e1ns Technical Risk Management

Avoiding costly recalls

The aim is to meet the planned costs and market launch times and to integrate approval-relevant work into the development process.

This can be achieved by consistent networking of user requirements and technical requirements with the functional structure and system architecture in one data model.

e1ns connects your teams across locations with modern web technology – a great advantage for the creation of FMEAs. Whether your employee is an FMEA specialist, an FMEA editor or another colleague, who uses the results or performs tasks.

All collaborators work on the same system model but have task-oriented access to the relevant information.

Your benefits

Why e1ns Risk Management 14971?

Integration of risk management into development planning

  • Integrating risk management into the development process promotes acceptance in the development team
  • Quick additions/changes through central management of data and analysis
  • Compliance with standards through uniform methods
  • Shortened approval procedures through a uniform layout for printing and approval circulation
  • Effective knowledge management through evaluations via database queries
  • Security through central monitoring of measures

The possibilities of e1ns web technology

  • Easy transition
  • Future-proof work
  • Shortened development times
  • Error-free products
  • Scalability
  • Minimized costs

Safety and reliability as the top priority

e1ns Design Control

e1ns Risk Management 14971

e1ns Technical Risk Management

Traceability of Requirements incl. V+V




Systems Analysis




Requirements and Functional Analysis




Specification (Design Input/ Design Output)




Risk Analysis




Risk Graph






Risk Governance




Risk Management Report




Failure Analysis








Measure Tracking, Newsletter




Questionnaire (Appendix C)





Recommended complement for your complete development process.

e1ns Design Control

e1ns Risk Management 14971

e1ns Technical Risk Management

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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