e1ns Risk Management 14971

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

	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	(RA)	(FMEA)
Risk Governance
Risk Management Report
Failure Analysis
FMEA Form
Measure Tracking, Newsletter
Questionnaire (Appendix C)	(optional)

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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