Connected, Compliant Medical‑Device Software
PerformaCode’s engineer team designs, migrates, and sustains software and firmware for Class II/III devices, aligning every line of code with IEC 62304 and ISO 13485 processes.
Where Software Bottlenecks Typically Start
Hardware Shifts
Devices often require firmware adaptation due to component changes, board redesigns, or product line updates. We handle migration, feature porting, and revalidation under strict industry regulation standards.
Connectivity issues
Device connectivity to hospital systems, imaging platforms, and other endpoints often involves multiple formats and protocols. We build and maintain stable, standards-aligned interoperability layers.
Compliance Load
Supporting IEC 62304 and ISO 13485 means thorough documentation, traceability, and repeatable testing. We support both automated and manual V&V to keep your release process aligned and ready for audit.
What we do
Embedded & Firmware Development
Board bring-up, driver development, and safety-critical firmware under IEC 62304 Class B/C. Includes system-level software, low-level resource optimization (CPU, memory, power), and performance tuning for embedded environments.
Legacy Software Migration
Code refactoring and porting to new hardware or OS versions, with customer-controlled efforts to support certification alignment. We aim to extend system lifespan while minimizing the need for full re-certification.
Connectivity & Interoperability
Standards-compliant data bridges and protocol handling (HL7, FHIR, DICOM, HIPAA, SDC), including modernization of legacy protocols to support integration with HIS, EMR, and cloud platforms.
Automated & Manual Testing
Verification and validation aligned with IEC 62304 and IEC 60601. We support test planning, execution, traceability, and mixed CI + manual workflows.
Sustaining Engineering
Ongoing updates, hotfixes, long-term maintenance, and optimization of existing software. Covers algorithm adaptation for new hardware, performance tuning in resource-limited environments, and remediation of defects or nonconformities identified during audits or as part of CAPA (Corrective and Preventive Action) activitie.
Simulation & Modeling
Custom environments and emulators for pre-clinical validation, hardware-in-the-loop and software-in-the-loop testing, as well as clinician training scenarios. Supports shift-left development by enabling early software prototyping before hardware availability.
AI/ML Integration Support
Engineering for ML-ready data pipelines, labeling infrastructure, and lightweight inference modules at the device or edge level. Designed to support regulated AI workflows without disrupting core firmware architecture.
Devices We Work With

Ventilators

Infusion pumps

Dialysis systems

Anesthesia machines

Defibrillators

Patient monitors

Central stations

Neonatal life support systems

Cardiac wearables

Imaging systems

Minimally invasive delivery systems
Trusted By Teams Building Regulated Devices
We integrate at any stage—design, development, porting, testing, or maintenance. Our engineers adapt to your roadmap without adding project noise.
We follow IEC 62304 and ISO 13485 processes in daily work. We support traceability, documentation, and risk control—without taking shortcuts.
We help design and maintain test setups: from HIL and simulation environments to regression automation and V&V artifact generation.
We bring practical understanding of clinical environments, connectivity needs, and fault scenarios—whether for ventilators, monitors, or minimally invasive systems.
Technologies & Tools
Embedded & Firmware
- C/C++
- ARM (Cortex-M/A)
- STM32
- Embedded Linux
- VxWorks
- LynxOS
- QNX
- FreeRTOS/SafeRTOS
- ThreadX
Connectivity & Integration
- HL7
- FHIR
- DICOM
- HIPAA
- UART
- BLE
- Wi-Fi
- Ethernet
- Custom protocols
Testing & Validation
- Robot Framework
- PyTest
- Google Test
- CUnit
- Parasoft
- VectorCAST
- Jenkins
- GitLab CI
- Coverity
- clang-tidy
Simulation & Modeling
- Hardware-in-the-loop (HIL)
- Custom simulators
- QEMU
- Simics
- Emulators
Signal & Sensor Interfaces
- ECG
- EEG
- SpO₂
- EtCO₂
- FiO₂
- IBP/NIBP
- Temperature
- Cardiac output
- Respiration
Legacy & Cross-Platform Support
- PowerPC
- x86
- MIPS
- Windows Embedded
- Android
- iOS
- bare metal
- Legacy board bring-up
Got questions?
Can you work with us if our project is already in progress?
Yes. We regularly join projects midstream—whether you’re in prototyping, migration, or verification. Our engineers adapt to your tools, coding standards, and QMS without disrupting your existing workflows.
Can we start with a small team or short-term task?
Yes. Many of our clients start with a single engineer or a clearly scoped pilot project, then scale once we’ve proven value and fit. In fact, we encourage starting small—especially for regulated environments—because we understand how critical trust, reliability, and seamless integration are in this space.
Do you follow IEC 62304 and ISO 13485 processes?
We align with both standards in our daily work. While final certification stays with your organization, we support compliance with traceable development, V&V documentation, and risk-based workflows.
Can you take over legacy firmware or migrate old code to new hardware?
Yes. We’ve worked on projects involving outdated schematics, unsupported processors, and complex feature migration. We help you modernize without risking recertification.
Do you build custom simulators or hardware-in-the-loop test setups?
We do. We’ve helped medical device teams build HIL rigs, emulators, and simulation environments for early testing, verification, or clinician-facing demos.
What kind of device interfaces and protocols have you worked with?
We’ve integrated devices using HL7, DICOM, FHIR, BLE, Ethernet, USB, and proprietary clinical protocols. We can build custom data bridges if needed.
Can you help us prepare for regulatory audits or documentation reviews?
Yes. We generate and maintain documentation that supports regulatory expectations (including IEC 62304 traceability matrices, V&V records, and risk control artifacts).
Are your engineers familiar with clinical environments and terminology?
We’ve worked with ventilators, infusion pumps, patient monitors, and wearable sensors. Our teams understand how these systems are used in real-world ICU, OR, and home settings.
How do you handle IP protection and data security?
All projects are governed by NDAs and strict internal controls. We follow secure coding practices and never reuse your code or documentation outside the scope of your project. We’re also fully prepared for client audits and follow your internal security policies and documentation standards as part of our engagement.
Need an Extra Set of Hands?
We can jump in at any stage—firmware, migration, integration, or testing.

