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We support you from test planning to verification

Medical devices must not fail in use. Every system must function reliably under all conditions. Increasing complexity, shorter development cycles, and strict normative requirements make accompanying test processes essential for product safety. Our system test team performs independent, comprehensive testing with deep system understanding. This results in verified products that withstand regulatory requirements and function reliably in real‑world use.

Learn how structured testing can help you validate your product development with confidence.

How we support your development

Exploratory Testing

Exploratory testing is a creative, experience‑based testing approach that can be applied at any stage of development. Without rigid scripts but with a structured strategy, it uncovers hidden defects, specification gaps, and system weaknesses, providing fast and independent feedback on system and product quality.

Scope of Services

  • Exploratory, experience‑based testing
  • Test tours in critical or failure‑prone system areas (e.g., connectivity, startup behavior, GUI)
  • Simulation of realistic and faulty user behavior
  • Boundary and edge‑case testing

Benefits

  • Detection of defects that are often missed by classical test approaches
  • Identification of hidden dependencies within the system
  • Prevention of software failures in edge‑case scenarios
  • Applicable throughout the entire development lifecycle
  • In‑depth testing by independent test engineers with development experience
  • Avoidance of late, costly design changes

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Testable Requirements & Test Case Design

Clear, testable requirements form the foundation for efficient verification and reliable product quality. Through structured requirements management and systematic test case design, gaps and defects are identified early—before they lead to increased cost or rework.

Scope of Services

  • Creation of a testable requirements baseline
  • Alignment and approval processes
  • Development of structured test cases (inputs, expected results, and acceptance criteria)
  • Equivalence class partitioning
  • Limit and boundary value analysis
  • Decision tables

Benefits

  • Clear, complete, consistent, and traceable requirements
  • Clear and repeatable test instructions to reduce misunderstandings
  • End‑to‑end traceability between requirements, risks, and test results
  • Increased patient safety and product quality
  • Reduced need for additional testing cycles

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Let’s talk about your requirements.

Design & Validation of Test Benches

Reliable test benches are essential for reproducible and standards‑compliant testing. By combining our hardware and software expertise with extensive development experience, we create robust test systems that meet the highest quality and safety standards.

Scope of Services

  • Design of test bench architecture, including hardware, software, and interface concepts
  • Software: implementation of control and test software using LabVIEW and Robot Framework
  • Hardware: sensors, measurement technology, and communication interfaces
  • Calibration and verification
  • Validation of test benches against specified requirements
  • Documentation, training, and handover

Benefits

  • Ensured accuracy, stability, and repeatability
  • Optimized test execution and traceability
  • Fast and precise acquisition, control, and analysis of measurement data
  • Increased patient safety and product quality
  • Reduced likelihood of defects during development and in the field

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Let’s talk about your requirements.

Automated Testing

Automated testing enables repeatable and efficient verification across all development phases. Through targeted automation of test workflows, system stability and development cycle times are significantly improved while reducing the risk of human error.

Scope of Services

  • Identification of suitable test areas and automation potential
  • Definition of automation frameworks and strategies (Robot Framework, LabVIEW, Jenkins)
  • Implementation of test cases (logging, reporting and error handling)
  • Integration of automated tests into build and release pipelines
  • Evaluation and categorization of test results

Benefits

  • Reduced overall testing effort
  • Minimized human error and consistently reproducible results
  • Immediate feedback through CI/CD integration
  • Automated logging and generation of test reports
  • Increased patient safety and product quality

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Let’s talk about your requirements.

Pre‑Compliance Testing (IEC 60601 Series)

Pre‑compliance testing enables the early assessment of a medical device’s conformity with regulatory requirements. Through targeted testing prior to formal certification, potential non‑conformities are identified early and can be addressed in a timely manner.

Scope of Services

  • Identification of applicable standards and requirements based on product class, intended use, and risk classification
  • EMC requirements (immunity, emissions – IEC 60601‑1‑2, EN 55011)
  • Alarm systems in medical devices (60601-1-8)
  • Electrical safety (Ableitströme, Isolation, etc.)
  • Additional IEC standards, e.g. 60601-2-25, 60601-2-27, 60601-2-30, 60601-2-4

Benefits

  • Early identification of potential deviations from applicable standards
  • Facilitated planning and execution of final certification testing
  • Increased patient safety and product quality

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Stress & System Testing

Stress and system testing evaluate the behavior of your medical device under real‑world and extreme operating conditions. They demonstrate how robustly and reliably all components interact—and help ensure long‑term performance and stability throughout the entire product lifecycle.

Scope of Services

  • Hardware, software, and mechanical testing
  • Vital parameter, communication, and GUI testing
  • Stress and endurance testing
  • Biocompatibility testing
  • Gas analysis (capnography, gas‑mixing test setups, and ventilation simulation)
  • Environmental and climatic testing (vibration, temperature, IP55, IP56)

Benefits

  • Additional, specialized testing to complement in‑house test activities
  • Comprehensive assessment of system stability and risk
  • Reduced likelihood of failures and material defects in the field
  • Increased patient safety and product quality

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Let’s talk about your requirements.

Our Service Packages for Your Success

Drawing on experience from numerous MedTech projects and close collaboration with leading manufacturers and startups, we offer tailored service packages designed to bring your medical device development to its goal faster, safer, and with confidence.

Let us help improve your processes.

 

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