e1ns Technical Risk Management

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 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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