Services Profile

Core competences

Project Management

Project planning and tracking
Coordination of project participants

Product realization

Development & Research
Electronics
Firmware & Software
Mechanical Design

Prototype Production

Production of prototypes with partners

Project controlling

Time, Budget,
Quality & Goals

Testing

In-House lab testing
External lab testing
Validation
Traceability

Quality Management

ISO 13485
FDA 21 CFR 820

Requirements Management

Design Input
Product & Design Requirements

Regulatory

Design Documentation
Risk Management
FMEA
Standards

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.
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Software Engineering Services

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According to Standards (IEC 62304, IEC 60601)
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

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According to Standards (IEC 60601)
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

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Prototype testing
01

Commissioning tests

02

Internal Laboratory tests

functional tests, long-term tests, …
03

External Laboratory tests

EMC, climate chambers, …
04

Traceability from input requirements through design to verification