Medical Software Contract Development
Bridging Medical Standards with Cutting-Edge Software Development
For nearly two decades, our team has lived at the intersection of software engineering and the medical device regulatory world.
We have grown with technology:
- From PHP and jQuery to enterprise Java and .NET systems
- From robust back-end architectures to modern React, Svelte, and Kotlin frontend solutions
At the same time, our focus extended to medical device projects, covering regulatory aspects and medical project requirements.
"We do not just write code. We build software that is compliant, reliable, and ready for the medical device market."
What Makes Our Software Development Different
- Experienced in design control processes aligned with international standards in medical device industry
- Skilled in preparing and maintaining technical documentation required for regulatory approval.
- Deep understanding of testing strategies and their connection to regulatory pathways.
- Ability to adopt development practices coming from your Quality Management System.
From Code to Medical Product Compliance
Developing medical device software is not only about writing robust code. It requires a structured approach that meets regulatory requirements while delivering modern, efficient, and safe applications.
Our unique advantage is that we:
- Combine strong engineering skills with regulatory insight
- Understand the standards, norms, and compliance rules that medical device software must meet
- Naturally embed regulatory thinking into every step of software development
"For us, compliance is not an afterthought. It is part of how we design and develop software from day one."
Software Development Aligned with Medical Device Compliance
Every organization has its own preferred way of managing software projects. Over the years, we have worked with:
- Agile methodologies
- V-Model approaches
- Robust waterfall models
We adapt to your internal procedures and ensure compliance with your quality management system (QMS) while staying aligned with other departments.
"Our team does not force one methodology. We bring experience with all models and adapt to yours while staying fully compliant."
Software Development Optimalization and Compliance Expertise
Beyond adjusting to your processes, we also contribute:
- Insights from past projects to highlight areas of improvement
- Recommendations for process optimization where beneficial
- The ability to seamlessly integrate without the need for extensive training
- A balanced approach where regulatory requirements and development efficiency go hand in hand
"No extensive training needed. We understand medical device rules and can start delivering from day one."
Agile Medical Device Software Development
Many companies ask whether Agile development can be applied to medical device software. We know it can, because we have proven it in practice.
- Experienced in running Agile processes under regulatory requirements
- Successfully passed multiple external audits with Agile-compliant setups
- Able to connect Agile flexibility with regulatory discipline
"Agile and compliance are not opposites. They can work together if managed correctly."
Our approach to Agile in regulated environments
- Tracking dependencies carefully: Even with changing requirements, we ensure all related processes stay updated.
- Risk management
- Cybersecurity controls
- Technical documentation
- Staying compliant without slowing down: We integrate regulatory deliverables seamlessly into Agile workflows.
- Balancing speed with safety: We combine rapid iteration with robust documentation and traceability.
This all allows us to:
- Enter new projects quickly without disrupting your QMS processes
- Deliver value while ensuring full regulatory compliance
- Provide clients with confidence that the product including technical documentation will pass any scrutiny
Software Developers Who Are Not Afraid of Norms
Medical device software development means working under strict rules, standards, and regulations. Many developers find these requirements intimidating. We do not.
"For us, norms and regulations are not barriers. They are tools that guide safe, reliable, and compliant software development."
We integrate these standards naturally into our daily work. From design inputs to testing and documentation, compliance is part of our process, not an afterthought.
IEC 62304 Compliant Software Development
IEC 62304 is the backbone of medical device software development. Our developers and teams know it in detail.
- From user requirements and software specifications
- Through architectural design, detailed design, and software unit decomposition
- To unit verification, integration testing, and system validation
We understand each stage, its terminology, and—most importantly—its value.
"IEC 62304 is not witchcraft. It is a structured framework we work with every day."
Our approach ensures projects are not only compliant, but also efficient, avoiding unnecessary complexity.
Cybersecurity by Design for Medical Device Software
Cybersecurity in medical devices is not optional. It starts on day one.
We follow the cybersecurity-by-design methodology, building security into every stage of development. Our experience spans enterprise solutions and end-user devices used across pharmaceutical and medical industries.
We work daily with:
- Threat modeling
- Vulnerability assessments
- Common Vulnerability Scoring Systems (CVSS)
- Connections to post-market surveillance and monitoring activities
"We do not just follow cybersecurity checklists. We know the standards and execute them independently."
We comply with IEC 81001-5-1 and ensure every project is secure, maintainable, and audit-ready.
Software Development Aligned with Risk Management
Risk management according to ISO 14971 is a natural part of our development process.
Our experience covers:
- Preliminary hazard and risk analyses
- Complete risk estimation and evaluation
- Risk control measures translated into additional software requirements
We do not only follow risk management procedures. We help organizations optimize them to fit real-world development workflows, making them practical and sustainable for their teams.
"Risk management is not a burden. When done right, it drives better software decisions."
Beyond the Core Standards: Building Compliance into Every Project
IEC 62304, IEC 81001-5-1, and ISO 14971 are just a beginning; we also cover:
- IEC 62366 (usability engineering for medical devices)
- FDA guidance and 21 CFR 820.30 requirements
- EU MDR 2017/745 and related regulations
We put these together into one integrated approach to medical device software development.
"Choosing us as your medical device software development partner means your product will be delivered fast, loved by users, and trusted by regulators."
Our software is:
- Secure and maintainable
- Regulation-ready for both EU MDR and FDA requirements
- Auditable, traceable, and built for long-term success