Medical Device Software Development Company

Developing software for a medical device is much more significant than creating a typical app. Since it sits right on top of the hardware, its reliability becomes a matter of patient safety. Every change must be fully tested and documented, and this responsibility does not end at launch. Manufacturers keep running into the same gap. The hardware team is solid, but the firmware team is weak. Quality problems then surface late, causing the release date to slip.

CHI Software is a medical device software development company and long-term engineering partner for MedTech manufacturers that need to extend their R&D capacity without handing over product ownership. We cover the full span of software development for medical devices, from embedded firmware and device control logic to connected apps, cloud backends, and applied AI. Our job is to strengthen your engineering output and documentation trail. Your team keeps ownership of the product, the quality management system, and regulatory accountability.

Medical Device Software Quality, Security, and Regulatory Requirements

Whether you answer to the FDA, the EU, or both, software engineering is woven into your regulatory obligations. Our work is designed to support your quality function, not replace it. We cannot and do not certify your product. However, we can produce the engineering artifacts and follow the lifecycle processes that will make your audits and submissions easier.

The regulatory baseline has recently changed. The Quality Management System Regulation was implemented in the United States on February 2, 2026. Manufacturers must now align their QMS with ISO 13485:2016 under the revised 21 CFR Part 820 framework (FDA QMSR). For teams still mid-transition, it is the time to close those gaps before audits follow. We align our deliverables with that framework and the standards your quality team adheres to.

Medical Device Software Lifecycle and Risk Management

We follow the software lifecycle processes described in IEC 62304 and incorporate them into your ISO 14971 risk management initiatives. This includes software requirements tied to risk controls, documented architecture, and a clear link between hazards, their associated controls, and the code that implements them. If the software has a user interface that affects safety, we also incorporate usability engineering under IEC 62366-1.

Software Verification, Validation, and Documentation

The quality of verification and validation depends on the evidence behind them. We produce requirements traceability, test protocols, test results, and the documentation set by your design controls. Our goal is to provide you with a clear and complete  record that can withstand scrutiny from reviewers and auditors.

Medical Device Cybersecurity and Data Protection

Device security is now a core safety issue, not an afterthought of the IT department. Healthcare is the most expensive industry for breaches; IBM’s research data puts the average cost of a healthcare security incident at $6.64 million, a number that lands differently when software security is built in from sprint one rather than patched later (IBM Cost of a Data Breach Report). We use threat modeling, secure boot, and signed over-the-air (OTA) updates. We also build a software bill of materials and data protection into connected components from the start. These measures support your response to current FDA premarket cybersecurity expectations and data protection rules in your target markets. In the EU, the picture spans more than one rulebook: the device itself sits under MDR, where ENISA guidance shapes how cybersecurity requirements are read, while connected companion software and other digital elements around it can fall under the Cyber Resilience Act (CRA). We help you map which part of a connected product answers to which regime, so nothing slips through the gap between them.

Our Medical Device Software Development Technology Stack

Technology choices follow the device, not the other way around. The technology that runs on constrained hardware with real-time limits differs from the technology that serves a cloud analytics platform. We select the stack based on the following: hardware, real-time requirements, connectivity constraints, cybersecurity needs, maintainability, and the environment in which your team already works.

Our teams work with embedded systems and real-time operating systems (RTOS) using C and C++ for firmware. We also work with Bluetooth Low Energy (BLE) and Internet of Medical Things (IoMT) connectivity stacks, as well as mobile development for iOS and Android companion apps. Additionally, we work with web applications, cloud infrastructure, and databases, including time-series stores for device telemetry. We also work with AI and machine learning frameworks for clinical analytics. Proven expertise and project-specific choices are not the same, and we will clarify this with you before you commit.