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Medical Technology

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Innovation, quality and cost-consciousness are all key drivers within global healthcare. Over the last 30 years, Noser Engineering has delivered versatile and cost effective solutions to life science, pharmaceutical and medical technology healthcare companies. Medical device technology requires a high degree of visualization, perfection and performance, as well as attractive and accessible user interfaces.

Services

  • Equipment, hardware and software development (IEC 60601, 62304 and others)
  • Development and documentation according to EU/US standards and directives (MDD, FDA)
  • Risk and quality management (ISO 14971, 13485)
  • Project management according to V-model, RUP, Agile, SCRUM
  • Development services
    • Proof of Concept
    • Analysis and Requirements Engineering
    • Architecture and Concept
    • Implementation
    • (Unit Test, Integrations Test, System Test, Code Analysis and Review)
    • Documentation and Training according to medical standards
    • Maintenance and Support

Our Competences


European Standards

  • 93/42/EEC Medical Device Directive (MDD)
  • 90/385/EEC Active Implantable Medical Device Directive (AIMDD)
  • 98/79/EC In Vitro Diagnostic Directive (IVDD)

FDA Standards

  • 21 CFR Part 820 - Quality System Regulation
  • 21 CFR Part 11 Electronic Records and Electronic Signatures
  • General Principles of Software Validation
  • Compliance on Off-the-shelf Software (OTS) used in medical devices

Applied Standards

  • Quality Management - Risk Management
    • ISO 13485 Our quality management follows the necessary core elements of ISO 13485.
    • ISO 14971 We can also support you with risk management according to ISO 14971 - be it with FMEA, PHA or FTA.
  • Software Development
    • EN IEC 62304 Through the implementation of EN IEC 62304, we ensure that the software fulfills the requirements of these directives.
    • EN IEC 62366 We support you to increase the usability and system requirements for the specification and implementation of the user interface. We also test and validate the suitability for use according to EN IEC 62366.
  • Hardware Development
    • IEC 60601-1 We develop electronics according to the general standard IEC 60601-1 as well as the applicable collateral standards IEC 60601-1 x.
    • IEC 61508 Where necessary or appropriate, methods of functional safety according to IEC 61508 can also be implemented to achieve and demonstrate the integrity of the required safety levels.

References


For more information click through to one of our Know How Centers or Technology, visit our Showcase or contact us directly.


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