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Medical Device Software

Because medical device software is more than just code.


Developing software for medical devices requires unique skillsets. Iron Rooster is an established provider of regulated software services for healthcare and medical technology companies. Our team manages the entire medical device software lifecycle including planning, analysis, development, testing, support, documentation, and ensuring compliance with regulatory requirements. We create, optimize and implement effective and transparent processes to ensure medical solutions are approved and reach the market faster.



  • Full lifecycle custom software development for medical software (Class I, II, III / A, B, C)
  • Regulatory compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304
  • Compiling 510(K) documentation
  • Creating standard operating procedures (SOPs)

Quality Management

A small error can take the shine off a great product.

Defective software leads to unsatisfied clients, unexpected work, and extra expenses. We help clients get the most out of their budgets by focusing the right resources on the right activities with the end result being satisfied users and clients. We establish scalable teams of test project managers, test leads, analysts, and manual and automation test experts that eliminate bugs and let solutions shine.



  • Continuous testing, agile testing, manual testing, test automation
  • Component, verification, system, integration, validation, acceptance testing
  • Web testing, mobile testing, API testing, desktop application testing, device testing
  • Jira XRay, TestRail, Jira Hiptest expertise
  • Selenium, Protractor, Sauce Labs, Postman, JMeter proficiency

Device Testing

Does your device function the way you say it should?

Over the course of 10 years testing devices, we have learned that it requires diversified knowledge to prove that devices work well and are developed in a manner that makes life easier for customers and users. We have developed a wide range of devices for varied uses across multiple platforms and technologies and have the experience needed to create devices that exceed expectations.



  • Testing on iOS and Android based mobile devices
  • IoT tools and Windows-based smart refrigerators
  • Test automation, manual testing, agile testing
  • Jira XRay, TestRail, Jira Hiptest expertise

Streamlining Documentation

Properly documenting your solution now will save you money later.

To ensure traceability, documentation for software as a medical device must meet strict regulatory guidelines and deliverables in order to demonstrate readiness for actual use. The written information accompanying a software product must be clear and concise and meet stakeholder needs. We have  dedicated specialists representing all stages of the software development lifecycle who are well-versed in developing documentation that adheres to the highest standards.



  • Comprehensive documentation for product planning, release and everything in between
  • A wealth of experience in preparing paperwork for various regulatory agencies, including the U.S. Food and Drug Administration (FDA)
  • Full development teams fluent in English and a team of translators to cover major European languages
  • Active knowledge of all the major tools and methods for producing, reviewing, approving and maintaining product documentation during and after the development process

510k Submission

You can’t afford for FDA compliance to be an afterthought.

The United States is one of the world’s largest markets for the healthcare industry due its unique combination of population, capital and overarching regulations. For medical device and software companies, adhering to FDA standards and regulations  is both complicated and absolutely necessary.  We have assisted multiple healthcare clients develop and document their solutions and have secured 510(k) clearance (previously known as premarket notification) for over a dozen solutions.


  • Identifying requirements for launching medical device software device in the U.S. market
  • Needs analysis determining best approach for securing FDA approval
  • Streamlined process for compilation of documentation
  • Support and guidance in reapproval process related to changes in intended use

Software Development Lifecycle

What’s the right process for the best outcome?

Everyone seems to view waterfall as bad and agile as good, but we have seen some pretty solid waterfalls, and several agile projects bite the dust. An agile label alone does not make a development process good. A good process is determined by its ability to consider the project, product and business goals, team, culture, communication, change management dynamics, and the risk awareness of the organizations involved. We learned these lessons over the course of 300+ software development projects, and we are happy to leverage this experience into value for our customers.



  • Identifying strengths and gaps in the development lifecycle
  • Determining if your development process meets your organizational goals
  • Assisting in build or refactor of your current SDLC
  • Ensuring that your software aligns with what matters – the value delivered

SOP Consulting

Your software also needs a solid foundation.

Standard operating procedures (SOPs) provide a foundation for building software by identifying precedence, laying ground rules, streamlining processes, and offering the transparency necessary for future optimization. Our experts rely on years of experience developing medical software to ensure our clients’ operating procedures reflect their needs while meeting the challenges of changing industrial trends. We can help improve existing SOPs or guide firms in building their own from the ground up.



  • Understanding the domain knowledge necessary to identify goals and the procedures necessary to attain them
  • Compiling comprehensive sets of rules and documentation to withstand the scrutiny of regulatory authorities
  • Balancing flexibility with standardization to ensure production remains predictable while still being responsive to new development models or technologies

Product Design

Digital experience can make or break your brand.

At Iron Rooster, if it’s not intuitive, it’s not a solution. We design products that users love, solve real problems, and boost innovation while reducing risk and saving money. We work with clients to understand their businesses and create solutions that meet their unique needs. We design user experiences that boost efficiency, and create  products that stand out from the competition.



  • UI/UX
  • research, user interviews, problem research
  • persona definition
  • process planning, wireframes, prototyping
  • usability testing
  • graphic design, click-through
  • build MVP
  • interactive design, information architecture
  • user story writing
  • requirement specification
  • agile methodology

Mobile Applications

Have you gone mobile yet? Your competition has.

A mobile application can kickstart your business, but only if it is designed with users in mind and in a way that performs flawlessly and intuitively. Whether developing on iOS, Android or a hybrid platform, Iron Rooster has talented and reliable resources to develop apps as imagined by our clients, on-time and within budget. We also support apps after their release to ensure continuous operation, feature addition, and modification as needed.



  • Android
  • Kotlin, Java, Machine learning, in-app purchases, Bluetooth, NFC, Retrofit, JUnit
  • iOS
  • Swift, SwiftUI, Objective-C, Machine learning, HealthKit, Wallets, In app purchase, Bluetooth, NFC, XCTest
  • Cross Platform
  • React Native, Xamarin Forms, Flutter
  • Integration
  • Firebase,, Fastlane

Web Technologies

Is a mediocre Web experience holding your business back?

Iron Rooster is committed to providing clients with practical web solutions, sleek and simple designs, clean code, and good architecture. We can help you build your technology from scratch or leverage your legacy systems to create a solution that will boost your business. We can also extend or optimize your in-house team with additional skillsets and resources. dd value to solutions by leveraging our extensive experience and world-class service.



  • Coding
  • JAVA, C#, JavaSript, TypeScript, PHP, Python, Ruby, C++, Delphi
  • Frontend
  • Database
  • SQL Server, Azure SQL, Oracle, PgSQL, MySQL, DB2, MongoDB, FireStore
  • Backend technologies
  • Java Spring, Java EJB, Java Struts, Hibernate, ASP WebForm, ASP.NET MVC, .NET WebAPI, Node.JS, NestJS, TypeORM, Laravel/Lumen, Symfony, Doctrine
  • Third Party integration
  • External API integrations, Google services, Firestore, Facebook

DevOps and Continuous Integration

If you are not quick and agile, you risk being left behind.

Agility in software development hinges on achieving a fast turnaround in getting new features to your users. At Iron Rooster we engineer efficient software delivery pipelines that ensure the builds, tests, deployments and monitoring of delivered systems. Our experts have considerable experience with all major cloud technologies, automated solutions for publishing mobile apps to the app stores and pipelines for microservice architecture..Whether developing or optimizing software delivery pipelines or needing us to create a custom one for our clients, Iron Rooster will make it happen.


  • Application operation
  • Source version control
  • Build automation
  • Continuous Integration
  • Jenkins, Bamboo, GitLab
  • Cloud technologies
  • AWS , Google Cloud, Digital Ocean , Azure
  • Development ecosystems
  • Atlasian (Bamboo, Jira, Bitbucket)


Even the most intuitive solutions require ongoing support.

You have developed a great product, now what? To keep customers happy and coming back, you must engage with them and respond to their needs. A support team is key to this process. We recognize that supporting our clients is not just about solving problems, but is also about developing valued relationships. This means honestly and proactively engaging with teams and users to ensure expectations are met. 


  • Multilingual communication
  • Chatbots, phone support, email support, live support
  • Hardware and software support

Project Management

Great teams need great leaders.

Every team requires coordination and leadership. In past years, leaders were called project managers. Today, the world prefers self-organizing teams guided by SCRUM masters and product owners. Our project management team consists of experienced leaders versed in agile methodology who can manage all aspects of a development project. We manage schedules, prioritization, risks, project scope and stakeholders to ensure that our clients achieve their business or product goals on-time and within budget.



  • Agile
  • Lean
  • PMP
  • Kanban

Innovative Technologies

Living in the past is no way to run a business.

The ability to innovate and adopt new technologies is what keeps companies  ahead of the competition. We can help leverage IoT technology to boost productivity, reinforce performance and create additional growth opportunities. We are intimately familiar with the data collection, dynamic user interfaces, and the advanced security required for such devices. We help clients take full advantage of today’s connected world and intelligent business environments.



  • IoT
  • Embedded Programming
  • Sensors, Actuators
  • Wireless Communication Protocols
  • Access Management

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