medical all devices

Medical

IAR provides a trusted, safety-certified embedded development platform that helps medical device makers build compliant, secure, and reliable software across wearables, implantables, imaging, robotics, and connected care.

 

Feature

Shape the future of healthcare with embedded software you can trust

Medical device software sits at the intersection of patient safety, regulatory complexity, and decade-long product lifecycles. From pacemakers and infusion pumps to imaging, surgical robotics, and connected hospital infrastructure, MDR, FDA, IEC 62304, IEC 81001-5-1, and the EU Cyber Resilience Act all converge on the same software.

IAR's safety-certified platform helps medical device manufacturers, OEMs, and contract developers turn that pressure into an advantage. TÜV SÜD-certified IEC 62304 tools up to Class C, integrated security preparing teams for CRA, advanced debugging and trace, certified code analysis, and CI/CD-ready build tools shorten certification cycles and reduce lifecycle cost. 

With support for Arm (Cortex-M and Cortex-A/R), RISC-V, Renesas RX/RL78/RA, TI MSP430, and STM8, IAR delivers vendor-agnostic flexibility and long-term toolchain stability, the platform you certify today is still the platform you ship a decade from now.

 

Applications

Across every medical technology application, IAR delivers software you can certify, secure, and sustain

medical wearable device

Patient monitoring & wearables

From consumer wrist to clinical evidence — ultra-low-power, secure, and ready for regulated use.

Wearables and remote monitoring platforms have crossed from fitness trackers into clinical-grade systems capturing cardiac rhythm, oxygen, temperature, and motion built on ultra-low-power MCUs like TI MSP430, Renesas RL78/RA, STM32L, and RISC-V cores.

IAR enables secure, ultra-efficient wearable development with optimizing compilers, secure boot and firmware signing, Power Debugging with I-jet, and TÜV SÜD-certified IEC 62304 toolchains, delivering up to 20–30% smaller code size.

medical pace maker

Implantable & life-support devices

Where deterministic execution is the difference between therapy and harm.

Pacemakers, infusion pumps, ventilators, and neurostimulators demand microsecond-precision control, EMC, and ultra-reliable execution across service lives measured in years, not release cycles built on Renesas RX/RL78, STM32, TI MSP430, and Arm cores under IEC 62304 Class C.

IAR delivers TÜV SÜD-certified toolchains up to Class C, deterministic compilers, and advanced debugging, generating up to 30% faster code so devices race to idle, extending battery life across 10–15 year lifecycles.

 

medical diagnostics imaging

Diagnostic imaging & laboratory automation

High-performance compute meets clinical data integrity.

CT, MRI, ultrasound, and X-ray systems rely on high-performance processors for signal acquisition, image reconstruction, and real-time control. Lab automation analyzers, sequencers, and robotic sample handlers demand precise motion and data integrity, typically on Arm, RISC-V, and Renesas RX/RZ platforms.

IAR delivers high-performance compilers, multi-core debugging, real-time trace, and certified analysis, cutting debug effort by up to 80% on complex imaging and motion workloads.

 

medical sirurgical robotics

Surgical robotics & assistive technologies

AI-driven precision, with safety interlocks you can actually certify.

Robotic surgery and computer-assisted platforms combine high-performance processors with precision motor control, sensor fusion, and AI-driven vision, coordinating multi-axis motion and enforcing safety interlocks across heterogeneous compute (Arm, RISC-V, Renesas RZ, AI accelerators) under IEC 62304 Class C.

IAR'sfunctional safety editions deliver optimized code, multi-core debugging, and certified analysis, cutting defect-related cost by up to 25% and accelerating safety-qualified product introduction.

medical telemedicine equipment

Telemedicine & connected hospital equipment

Connected care, without the cybersecurity compromise.

Hospitals deploy more networked devices than ever for monitoring, drug delivery, surgical support, and asset tracking, while telemedicine moves clinical data between patient homes, cloud, and clinicians, with every endpoint under MDR/IVDR, IEC 62304, IEC 81001-5-1, and CRA scrutiny.

IAR enables connected device development with architecture-agnostic tooling, integrated security (secure boot, signing, anti-rollback), and CI/CD-ready build tools, cutting build times by up to 50%.

Global - Engineering medical devices - Shawn only

Live webinar - Engineering medical devices

Don't let compliance slow your next release

Learn how to escape end-of-cycle compliance scrambles and turn IEC 62304, FDA, and CRA pressure into faster releases, stronger security, and continuous audit-ready evidence. 

IAR platform

IAR: The platform of choice for medical devices

Why medical device OEMs choose IAR

  • One certified toolchain across implantables, wearables, imaging, robotics, and connected hospital systems, no fragmentation across product lines.
  • Lower lifecycle cost through reusable software platforms, deterministic performance, and toolchain stability that outlasts your roadmap.
  • Reduced certification risk with TÜV SÜD-certified IEC 62304 tools (up to Class C), certified code analysis, and built-in security aligned with the CRA. 
  • Faster submissions enabled by CI/CD-ready build tools, containerized workflows, and automated quality gates that produce audit-ready evidence.
  • Future-proof investments through broad MCU/MPU coverage, architecture flexibility, and a strong medical silicon ecosystem. 

Why contract developers and Tier-1 suppliers rely on IAR

  • Pre-qualified safety toolchains that reduce IEC 62304 qualification effort and audit overhead across customer projects.
  • Automated MISRA C/C++, CERT C/C++, and CWE analysis embedded in CI/CD for continuous evidence generation.
  • Consistent multi-architecture support across Arm, RISC-V, Renesas RX/RL78/RA, STM8, TI MSP430, and more, reusable across customers, devices, and submission types.
  • Highly optimizing C/C++ compilers that reduce BOM cost, right-size MCUs, and deliver deterministic performance for safety-critical subsystems.
  • Integrated secure boot, firmware signing, and CI/CD workflows that scale across regulated projects, validation environments, and customer platforms.

Why developers love IAR

  • Advanced debugging with real-time trace, timeline views, profiling, Power Debugging, and RTOS awareness, built for timing-critical and power-critical medical code.
  • Built-in code quality and safety tools: certified static analysis (MISRA C/C++, CERT C/C++, CWE) and runtime checks that catch defects before they reach verification.
  • Faster builds and iterations with IAR Build Tools, supporting local and containerized CI/CD pipelines.
  • Industry-leading optimization that generates compact, fast, and reliable code for power-constrained and performance-critical medical applications.
  • Modern workflows: VS Code, Eclipse, GitHub/GitLab, containers, and long-term reproducibility, without giving up the IAR toolchain you certified on.

Strong ecosystem

Where safety, security, and connected medical innovation come together

Modern medical device development connects safety-certified toolchains, end-to-end security, and DevSecOps pipelines across diverse MCU and MPU platforms, powering the next generation of safe, secure, connected medical devices.

embedded trust security encryption - focus

Security-by-design for connected medical devices

Secure boot, signed updates, anti-cloning, and trusted provisioning built in, not bolted on

Medical devices connected via Bluetooth, Wi-Fi, or the cloud face a growing range of attack vectors, and managing patches across decade-long lifecycles is complex enough without late-stage security bolt-ons.

IAR Embedded Trust, Embedded Secure IP, and Secure Deploy provide secure boot, firmware signing, anti-rollback, IP protection, and trusted OTA deployment, fully integrated within the IAR Platform and aligned with FDA pre-market cybersecurity guidance and the EU Cyber Resilience Act.

c-stat code quality report

Shift-left compliance with code quality and certified analysis

Static and runtime analysis embedded in the developer's workflow, not at the end of the cycle

Most compliance delays happen when verification arrives too late. Shift-left embeds risk, security, and validation into the developer's environment, making verification a continuous activity rather than an end-of-cycle scramble.

IAR C-STAT enforces MISRA C/C++, CERT, and CWE rules at build time, while IAR C-RUN catches bounds, overflow, and heap errors before verification. Both produce auditor-ready artifacts mapped to IEC 62304 and ISO 14971 activities.

analyzing CI build performance-1

DevSecOps for regulated medical software

Reproducible CI/CD pipelines built for IEC 62304, FDA, and CRA evidence

Fragmented tools and workflows across embedded, cloud, security, and quality teams compound as medical software grows more connected and more regulated. Unified DevSecOps-ready pipelines make every change traceable and every build reproducible.

IAR Build Tools support headless, containerized CI/CD across Jenkins, GitHub, GitLab, and Kubernetes. Combined with IAR C-STAT, C-RUN, and Embedded Trust within the IAR Platform, teams generate audit-ready evidence as part of every build, supporting IEC 62304, FDA, and CRA expectations.

What drives your focus?

Find the path that moves your medical program forward

Whether you're shaping safety-certified medical platforms, leading engineering teams through IEC 62304 programs, or evaluating tools for the next wave of connected medical devices, choose the path that matches your goals.

Medical leadership & strategy

Looking for trusted, safety-certified medical solutions?

Explore how IAR's platform supports IEC 62304 programs up to Class C, IEC 81001-5-1 cybersecurity, and CRA readiness,  reducing certification risk and enabling reliable development across wearables, implantables, imaging, robotics, and connected hospital systems.

Engineering productivity & workflows

Leading technical teams building complex medical systems?

Discover workflows optimized for deterministic performance, safety, security, and long-term maintainability, covering compilers, debugging, real-time trace, code analysis, secure boot, and CI/CD across Arm, RISC-V, and proprietary architectures.

New to medical software modernization

Evaluating tools for next-generation medical devices?

Get an overview of how modern embedded toolchains support safety-critical control, secure connectivity, and long-lifecycle products, reducing program risk and shortening time-to-market for both legacy and next-generation medical platforms.

Webinar

Engineering medical devices for the IEC 62304 and CRA era

The fastest medical device teams aren't doing more compliance work, they're building it into how they engineer.

Learn how TÜV SÜD-certified toolchains, integrated security, and CI/CD workflows produce audit-ready evidence continuously, moving safety and compliance left across the product lifecycle.

Global - Engineering medical devices - Shawn only

Customer cases

Get inspiration on how world-leading companies enhance their embedded development with our solutions.

osong office

Faster development, smaller code, longer battery life for smart medical platforms

Osong Medical Innovation Foundation (KBIO) develops advanced medical devices and smart healthcare platforms. By adopting IAR Embedded Workbench, the team reduced executable code size, enabling device miniaturization, and used Power Debugging with the I-jet probe to optimize current consumption for wearables.

Build times are at least twice as fast as alternatives, shortened development cycles, and the foundation is upgrading to IAR's functional safety edition for future certification needs.

heroic faith medical device screens in operation room

Securing AI-based respiratory monitoring and accelerating FDA certification

Heroic Faith Medical develops AI-based continuous respiratory monitoring instruments and electronic stethoscopes. The team adopted IAR Embedded Trust to deliver the data encryption, security, and stability their AI recognition platform required.

Comprehensive 4A security (anti-cloning, active IP protection, anti-rollback, authentication) protected firmware against tampering and simplified FDA submissions, letting the team focus on research rather than certification overhead.

model based design visual state

Communicating complex device designs with confidence and perfect fidelity

Sunrise Labs is an ISO 13485-certified contract developer with 20+ years of experience turning novel medical device ideas into commercial products, from wireless battery-powered devices to complex multi-tasking systems.

Using IAR Visual State, the team specifies, verifies, and generates code for sophisticated device behaviors, keeping designs clear across clients, developers, and risk management teams.

apexbio-products

Shortening development time by 10–30% across IVD product lines

APEXBIO is a leading biosensor company developing blood glucose, ketone, cholesterol, and HbA1c monitoring systems sold in over 80 countries and approved by the FDA and CE. The team has used IAR Embedded Workbench since 2004 across Arm, MSP430, and STM8.

APEXBIO estimates 10–30% shorter development time compared with other major IDEs or open-source, and has upgraded to the functional safety edition to meet IEC 62304 requirements.

Interactive demo

Build medical devices patients can rely on

 See how modern, safety-certified toolchains support life-critical control, secure connectivity, and long-lifecycle development, moving quality, safety, and compliance left across the medical software lifecycle. 

Compliance

Ensure safety compliance from start

Our solutions are TÜV SÜD certified 

tuv sud

As embedded systems grow more complex, functional safety becomes crucial, especially in industries like MedTech where compliance is mandatory. 

Our functional safety editions are TÜV SÜD-certified, ensuring they meet the necessary standards for developing safety-critical applications. By choosing IAR as your development platform, you eliminate the need to independently evaluate the tool’s development process or conduct your own compliance testing. TÜV SÜD has already handled this, saving you both time and costs, so you can focus on your code and application features. 

Functional safety

Supported standards IEC 62304

The international standard IEC 62304 specifies life cycle requirements for the development of medical software and software within medical devices.

The IAR certified toolchains are suitable for use in safety-related software development according to IEC 62304:2006+A1:2015 for any software safety class (up to Class C - life-threatening).

Our certified architectures

  Arm RISC-V Renesas RL78 Renesas RX STM8
Medical IEC 62304 (up to Class C) checked checked checked checked checked

Supported devices

The platform for embedded development

How our solutions help you

Scale development operations with freedom and flexibility, accelerate innovation with code confidence and simplify compliance while strengthening security.

green developer board with microcontrollers and chips

Architecture and device agnostic

Develop without limits on 20+ architectures

IAR’s platform supports multiple architectures like Arm and RISC-V, ensuring compatibility, eliminating vendor lock-in, and simplifying development across legacy and next-generation embedded systems.
one developer screens with code

Cloud-ready, tailored for enterprises

Scale seamlessly with cloud-powered development

Seamlessly integrates with private, public, and hybrid cloud environments, enabling remote collaboration, scalable builds, and CI/CD automation while ensuring security, compliance, and efficient resource management.
hands of developer and screen with code

Functional safety always included

Ensure safety compliance from the start

Pre-certified tools ensure compliance with ISO 26262, IEC 61508, and IEC 62304, reducing certification complexity and helping teams build reliable, safety-critical applications in automotive, medical, and industrial systems.
developer code on screen

End-to-end embedded security

Secure your embedded systems at every stage

Built-in security features like secure boot, encrypted code, and runtime integrity verification protect against cyber threats, ensuring compliance with NIST, the Cyber Resilience Act (CRA), and ETSI standards.

Interactive demo

Experience the IAR platform

See how the IAR platform and its solutions work and what the interfaces look like.

Platform wheel without header bigger canvas

IAR embedded development platform

Get access to all

Scale development operations with freedom and flexibility, accelerate innovation with code confidence and simplify compliance while strengthening security.

  • Architecture and device agnostic
  • Cloud-ready, tailored for enterprises
  • Functional safety always included
  • End-to-end embedded security

With our platform you get access to everything.