Service profile
Core competences
Project Management
Project planning and tracking
Coordination of project participants
Coordination of project participants
Project controlling
Time, Budget,
Quality & Goals
Quality & Goals
Requirements Management
Design Input
Product & Design Requirements
Product & Design Requirements
Product realization
Development & Research
Electronics
Firmware & Software
Mechanical Design
Electronics
Firmware & Software
Mechanical Design
Testing
In-House lab testing
External lab testing
Validation
Traceability
External lab testing
Validation
Traceability
Regulatory
Design Documentation
Risk Management
FMEA
Standards
Risk Management
FMEA
Standards
Prototype production
Production of prototypes with partners
Quality management
ISO 13485
FDA 21 CFR 820
FDA 21 CFR 820
Processes
Product Development Stages
I support my customers through the complete design process of Medical Devices with strong experience in stages from idea to production transition.
1
Idea stage
Market requirements
Definition of product
Software Engineering Services
01
Complete software product lifecycle
02
Requirements management
03
Architectural design
modularization, segregation
04
Detailed design
05
Implementation
06
Design documentation
07
Module, integration and acceptance tests
including static and dynamic tests
08
Software risk & usability management
09
Software release and change management
10
Usage of requirements / lifecycle management tools
Helix ALM
Electronics / Hardware Engineering Services
02
Requirements management
03
Concept development
04
Schematics design and simulation
05
Proof of concept design
06
PCB layout
EMI compliant
07
Design for production
testability, producibility, industrial design
08
Risk Management, FMEA and Usability
09
Design documentation
10
Usage of requirements / lifecycle management tools
Helix ALM
Testing
01
Commissioning tests
02
Internal Laboratory tests
functional tests, long-term tests, …
03
External Laboratory tests
EMC, climate chambers, …
04
