The approval of medical devices in Europe is subject to many regulations. To fulfill these requirements, medical technology companies start early in the development process and work in accordance with the required standards and guidelines.

One of the main standards is risk management according to DIN EN ISO 14971.

e1ns Risk Management 14971

Identify complex interactions and avoid expensive recalls at an early stage

e1ns Risk Management 14971 focuses on standard-compliant risk analysis, in which the corresponding hazards and risks for the user are identified from the operating steps of a medical device. These are reduced to an acceptable level using risk-minimizing measures.

The implementation and effectiveness of the measures are monitored and documented using the risk control method.

e1ns Risk Management 14971 is database-driven and enables the connection to Design Control and Technical Risk Management, Knowledge and Template Management as well as Lessons Learned. The application is handled via the web browser – simple, convenient, available, and networked.

The results are displayed at the push of a button in graphical (risk graph) and tabular form (list of risk dominating measures, extract from risk analysis, hazard list, etc.).

software screen zu risk management 14971

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

Comparison of the e1ns solution packages in medical technology - focus on risk management 14971

Recommended additions for your complete development process

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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