e1ns Design Control

The Design Control process describes the process of product development and provides the specifications for technical product development. The system analysis describes the product to be developed theoretically through the steps of requirements definition, functional analysis, logical architecture design and component specification and specifies the resulting product models.

e1ns Design Control

Transparent development processes for all parties involved

The Design Control Process is designed to improve the safety and efficiency of medical device development. e1ns Design Control focuses on the traceability of user needs from design input to design validation.

e1ns Design Control and System Analysis is database-driven and enables knowledge and template management as well as lessons learned process. The application is handled via the web browser - simple, convenient, available, networked. Results - from user requirements and risk-minimizing measures to product function and specification - can be displayed and output graphically in block diagrams, navigable network structures or tables at the touch of a button.

Thus, problems and interdependencies can be identified more quickly and resolved in a targeted manner. e1ns Design Control not only supports new developments, but also changes and further developments of medical devices.

The application of Design Control is required by the FDA for the product development of medical devices and more precisely defined in FDA 21 CFR 820.30. In Europe, this term is almost identically dealt with in DIN EN ISO 13485 in Section 7.3 Design and Development.

With e1ns Design Control, you can achieve this through a traceable and consistent networking of methods, data and documents from risk management to technical product development.

Your Benefits

Why e1ns Design Control?

Integration of risk management into development planning

Integration of risk management into the development process promotes acceptance within the development team.
Fast additions / changes through central management of data and analyses.
Security through central action monitoring.
Effective knowledge management by graphical evaluations and database analyses.
Shorter approval times thanks to uniform and up-to-date product files at the touch of a button.

The possibilities of e1ns web technology

Simple transition
Future-proof work
Shorter 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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