Looking to start medical device software development? Learn the critical steps, from regulations and usability to scaling and partner selection.

Discover comprehensive insights into medical device software development. Learn about regulatory frameworks, compliance, and best practices to ensure successful implementation.

Jan 25, 2024 · This guide provides an overview of IEC 62304, clarifies terminology, and addresses misconceptions in medical device software development.

Jul 22, 2025 · Explore the intricacies of medical device software development, ensuring a deeper understanding of the pivotal steps and processes involved.

Mar 13, 2024 · Meticulous medical device software design, development, and lifecycle management practices are key for engineering teams to build safe, usable, and efficacious …

Nov 5, 2025 · This article unpacks the five phases of medical device software development, pinpoints where teams commonly go wrong, and outlines how disciplined engineering leads to …

Use of Software as a Medical Device is continuing to increase. It can be used across a broad range of technology platforms, including medical device platforms, commercial "off-the-shelf"...

Jun 12, 2025 · In this commercial-grade guide, we reveal exactly how our nationwide team of healthcare IT professionals takes your vision and builds it into secure, scalable, and regulation …

May 5, 2025 · In this guide, I want to help demystify these devices and offer you insight into how they’re regulated and what you can expect as you set out to build one. Let’s take it from the …

Jun 3, 2025 · When developing healthcare software that could potentially qualify as a medical device, obtaining FDA approval is a crucial step. It ensures your product is safe, effective, and …

Mar 13, 2025 · Medical device software development focuses on designing applications that work within or alongside medical devices to support diagnostics, monitoring, and treatment. These …

Apr 22, 2024 · What Is Medical Device Software Development? This is the process of designing and building apps that integrate with medical devices to deliver health-related functions. …

Sep 17, 2020 · But as exciting as all of this sounds, building compliant medical device software for connected devices isn’t simple. These tools—whether a physical device or pure software—are …

NOVO provides comprehensive ISO-certified medical device development & engineering services nationwide from San Diego and Minneapolis.

IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard …

Learn all you need to know about medical device software development: device types and use cases, development steps, practices, and challenges.

Nov 17, 2025 · Catch highlights from the Kablooe open house—design demos, product showcases, and conversations on human factors and engineering for medical devices.

Design Solutions offers professional, comprehensive, and cost-effective medical product development engineering services for clients in the medtech sectors.

Nov 4, 2025 · If you’re exploring medical device software development, this step-by-step guide explains how it works, how much it costs, and what to expect. Written for founders aiming to …

Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff Document issued on September 28, 2022.

Mar 23, 2025 · Guide to medical device software development covering key regulations, best practices, and lifecycle steps for delivering safe, effective healthcare solutions.

Apr 12, 2024 · There are a number of design and development companies that specialize in these services to help companies turn their great ideas into a functional, compliant and commercially …

Zebra's barcode scanner software lets you keep devices current and adapt them to your business needs for a stronger ROI across the full lifecycle. RFID development, demonstration and …