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How to Build Medical Device Software Design – Ultimate Guide

In healthcare, medical device software help with a number of purposes, from data acquisition and analysis to remote monitoring and quality control. However, medical device software design requires careful planning and strict compliance with various standards and regulations.

In today’s blog, we will discuss everything from what medical device software is and its benefits to the standards used for medical device software design. Moreover, we will discuss each step involved in building medical device software design.

From defining the technological stack and understanding various requirements to building a development team and consulting health and tech experts, we will cover everything in detail.

So let’s start:

What is Medical Device Software?

Medical device software is a computer program that is particularly designed for healthcare applications. It is the component of a medical device that helps the device function and perform the tasks that it is built for.

If we have to explain in simple words, medical device software is like the control center of a medical device. It enables the medical device to carry out functions like monitoring and analyzing data along with controlling device operations.

How Does Medical Device Software Benefit Healthcare Practices?

Using medical device software has a number of benefits for healthcare practices. Not only does it help practices in improving efficiency by automating tasks such as patient data management and appointment scheduling but also helps them in reducing administrative burden.

Moreover, medical device software can help in making patient care better through accurate and timely data analysis, treatment planning, and monitoring. In addition, it helps practices in being compliant with regulatory standards while facilitating audits and reducing errors significantly.

How to Build Medical Device Software Design?

Define the Technological Stack:

The very first step in building medical device software design is to determine if the medical device is purely embedded or software as a medical device.

This won’t just help you in understanding the specific requirements of the project but also have a deep understanding of the constraints related to the project.

Understand FDA and HIPAA Requirements:

Once the technological stack is defined, it’s time to understand various regulations set by the U.S. Food and Drug Administration (FDA) and Health Insurance Portability and Accountability Act (HIPAA).

For some medical device software designs, you may also need to be compliant with ISO certifications and other industry standards.

Build a Capable Development Team:

In the third step of building medical device software design, the project scope is defined, and based on that a team of developers is formed considering the expertise of developers.

When building a team of developers, look for professionals who have experience in the medical device industry so that they can better understand the unique challenges and considerations of software design.

Consult a Health-Tech Engineer:

When you are done with building your development team, start consultation with an expert health-tech engineer who can design the software/device system specifications.

Make sure the health-tech engineer has a deep understanding of the medical field and he must be able to translate the technical requirements into a design that meets both regulatory standards and user needs.

Get a Skilled Project Manager On Board:

In this step, get a project manager on board who has experience in managing complex software development projects, particularly in the medical domain.

The project manager will break down the overall project into various phases and tasks, moreover, he will set timelines and allocate resources to ensure smooth coordination among team members.

Allocate Tasks to Specialists:

Now when the team is finalized, identify the specific tasks required for the project and assign them to the appropriate specialists.

Health-tech UI/UX designers will be assigned the role of creating an intuitive user interface while back-end/front-end developers will be responsible for software development. Similarly, quality assurance experts will take care of testing and validation, and other relevant experts are assigned tasks based on their expertise and project requirements.

Involve Medical Professionals:

In the end, you need to make sure that you have medical professionals available for consultation and testing throughout the development process.

From physicians and surgeons to nurses and other healthcare experts, everyone must be involved as end-users of your medical device software.

What is the Standard for Medical Device Software Design?

There are two standards ISO 13485 and ISO 14971 that cater to medical device software design. Here below we have discussed both of them:

ISO 13485:

This standard takes care of quality management for the design and manufacturing of medical device software. Moreover, it details the requirements for quality management in medical device software design.

In addition, the standard focuses on ensuring that manufacturers maintain processes to meet regulatory and consumer requirements.

ISO 14971:

This ISO standard addresses risk management in the medical device software industry. It provides guidance on the application of risk management to medical devices.

Furthermore, it emphasizes the identification, assessment, and monitoring of all kinds of risks associated with medical devices to ensure their safety and performance.


Building medical device software design requires careful consideration and adherence to industry standards. It is essential to prioritize safety, reliability, and user-friendliness throughout development.

Moreover, thorough research and requirement analysis are key to creating robust and compliant software while collaboration among team members and close communication with regulatory bodies ensure the successful implementation of medical device software.

By following these guidelines, developers can build medical device software that meets the highest standards of quality, functionality, and patient safety in the healthcare industry.

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