MATLAB and Simulink for In Vitro Diagnostic Devices

Design, simulate, and test in vitro diagnostic (IVD) devices

MATLAB® and Simulink® enable engineers, researchers, and scientists to design, simulate, and test in vitro diagnostic (IVD) devices while complying with industry regulations and standards. You can validate MATLAB and Simulink products for FDA/CE regulations and conform to standards such as IEC 62304 in the development process.

With MATLAB and Simulink, you can:

  • Design and simulate algorithms for sensor data and control systems
  • Simulate and analyse life science data, including multi-omics, microscopy, and mass spectrometry
  • Create and validate artificial intelligence (AI)-based in vitro diagnostic applications
  • Advance life science data processing and AI models with parallel and cloud computing
  • Develop IEC 62304-compliant embedded software with full requirements traceability

“MathWorks tools are integral to the custom analysis work that we perform. MATLAB frees us to focus on data analysis instead of programming. It greatly speeds up our coding process.”

Dr. Hongyue Dai, Rosetta Inpharmatics/Merck & Company

Designing and Simulating Algorithms for Sensor Data and Control Systems

With MATLAB and Simulink, you can integrate different physical domains in a unified simulation environment to efficiently design and test complex IVD devices. You can simulate electro-mechanical and fluidic components, data sensors, and advanced algorithms. Simulations help in system design that needs to ensure the interoperability of algorithms, sensors, and multidomain components in a hardware-independent environment.


Simulating and Analyzing Life Science Data

You can use MATLAB and Simulink to analyze multi-omics, image, time-series, microscopy, and other data for different tasks and applications in the life sciences. You can also combine functions to support common bioinformatics workflows such as next-generation sequencing (ChIP-Seq, RNA-Seq), microarrays, and mass spectrometry data. SimBiology enables the modeling, simulation, and analysis of complex biological systems and its application to IVD and drug development.


Creating AI-Based In Vitro Diagnostic Applications

MATLAB and Simulink enable AI-based IVD applications such as identifying drug targets and classifying image data. You can work with common AI frameworks such as TensorFlow and PyTorch and integrate AI into the complete workflow for developing IVD applications. Using Model-Based Design, you can integrate verification and validation into the development process for FDA/CE regulatory compliance.


Advancing Life Science Data Processing and AI Models

With MATLAB and Simulink, you can advance life science data processing for compute-intensive tasks such as high-throughput screening and mass spectrometry data analysis. You can optimize algorithms for performance and automatically generate code for target processors such as GPUs or FPGAs. You can create your own computing infrastructure with parallel servers to support big data analysis. MATLAB also supports public cloud providers such as AWS, Azure, and NVIDIA GPU cloud.


Developing IEC 62304-Compliant Embedded Software

You can develop IEC 62304-compliant embedded software for surgical devices using Model-Based Design with MATLAB and Simulink. Model-Based Design incorporates verification and validation into the software development workflow, and therefore, establishes a common framework for designing safe and tested software for medical devices. Most of the documentation required by the IEC 62304 standard is automatically created with full traceability.


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