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26 - 28 February 2019 // Nuremberg, Germany

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Exhibitors & Products embedded world 2019
Zoom product LOGO_Medical Engineering

Medical Engineering

LOGO_Medical Engineering

Medical Engineering

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Engineering Services

Developments in the fields of medical technology and laboratory automation require significant technical know-how and knowledge of standards. We develop your new products, electronic components and accessories from scratch. Alternatively, we can develop and enhance existing products or carry out subtasks for you. This will enable you to bring your products to the market in a timely manner, in compliance with standards and in line with the state of the art.

Specification

In the first step of product development we develop basic product related concepts and specification:

  • Product-/system specifications
  • Software- and hardware
  • Functional safety (single fault safety)
  • Test specification
  • Support in risk analyses and performance of FMEAs

Implementation

Step by step we develop software, firmware and hardware. Each step includes development documentation fit for approval (Device Master File):
 

Software/Firmware

  • According to EN 62304 for all software safety classes A/B/C
  • Consideration of customised or own design and coding standards

Hardware

  • Consideration of EN 60601-1
  • EMC-safe PCB-layouts

Further activities

  • Setup of demonstrators and prototypes
  • Test engineering and verification
  • Environmental tests and EMC-measurements in own or accredited test laboratories  

Certification, Serial Transfer, Product Life Cycle

Our activities go far. We also support you with:

  • Certification and approval processes (e.g. CE, FDA, UL)
  • Transition to series production
  • Selection of suitable producers
  • Production of initial samples
  • Sustaining engineering, e.g. optimisation of production costs and design, component searches and implementation of redesigns when components are discontinued 

Consulting

We would like to support you with our long standing experience:

  • Drawing up technical concepts which, in particular, deal with functional safety (single fault safety), and doing expert reviews of these
  • Appraisal and revision of documents that are relevant for approval
  • Providing support for risk analysis and advice on issues relating to the development process

Competencies

  • Medical devices risk class
    I, IIa/IIb, III
  • In-vitro-diagnostic
  • Software safety classes A/B/C
  • Embedded software development
  • Medical Apps
  • HMI design incl. usability engineering
  • GUI / HMI implementation
    e.g. with Qt, Segger
  • Connection to the HIS hospital information system (HL7, GDT)
  • Storage battery management, e.g. for lithium-ion battery technology

We Work according to following Directives and Standards

  • 93/42/EEC Medical Devices Directive; amended by 2007/47/EC;
    21 CFR Part 820
  • EN / UL 60601-1
  • EN 60601-1-X
  • EN 60601-2-X
  • EN 61010
  • EN 62366
  • EN 62304
  • EN ISO 14971
  • IEC 61508  

Certified Quality Management System according to

  • ISO 9001
  • ISO 13485

Industrial Automation

LOGO_Industrial Automation

Mobile Automation

LOGO_Mobile Automation

Process Automation

LOGO_Process Automation

Energy & Drives

LOGO_Energy & Drives
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