Rushing straight into coding without proper groundwork is one of the most expensive mistakes we see, and it’s completely avoidable.

Think of it this way: you wouldn’t start building a house without planning permission, architectural drawings, and the right team in place. Medical device software development requires the same thoughtful preparation, but with the added complexity of strict regulatory requirements that can make or break your route to market. 

Over the years, we’ve developed a comprehensive readiness checklist that ensures projects start on solid foundations. This isn’t about creating unnecessary bureaucracy – it’s about setting your project up for success and avoiding costly rework down the line. The good news? We’re here to help you tick every box. 

1. Your Quality and Regulatory Foundation

Before a single line of code is written, you need the right people and systems in place to ensure your software meets medical device standards (e.g. ISO 13485, IEC 62304). 

Quality Manager Appointed: Whilst ISO 13485 doesn’t mandate a quality manager (though you must define quality responsibilities), we’d strongly advise someone have overall responsibility. Whether you hire someone in-house or engage an external consultant, you need a dedicated Quality Manager who understands ISO 13485 inside out. This person will be your guardian angel throughout development, ensuring every decision aligns with your Quality Management System and regulatory requirements. At Firefinch, we often see startups initially resist this investment, but it pays for itself many times over by preventing compliance issues later. 

Regulatory Affairs Support: Medical device regulations are complex and constantly evolving. If your team doesn’t include someone with deep regulatory expertise, bring in a consultant. They’ll help navigate the maze of FDA, MHRA, or EU MDR requirements specific to your device class and intended markets. This expertise is crucial for making informed decisions about software architecture, documentation requirements, and validation strategies from day one. 

Quality Management System (QMS) Implementation: Your QMS isn’t just paperwork – it’s the backbone of compliant medical device development. Before we can integrate our development processes with yours, we need to see a fully implemented QMS with all necessary documentation and procedures in place. This includes design controls, document management, risk management procedures, and change control processes. Our team must be thoroughly familiarised with your QMS framework to ensure seamless collaboration and maintain compliance throughout the project. 

Medical device software development operates within a complex regulatory landscape, and everyone involved needs to understand the rules of the game. 

Regulatory Familiarity: Your team focusing on software component development should demonstrate a solid understanding of key standards, including AAMI TIR45 for agile development practices, ISO 13485 for quality management, and IEC 62304 for software lifecycle processes. These aren’t just theoretical concepts – they’ll shape every aspect of your software development approach. If your team is new to these standards, invest time in training or bring in expertise before development begins. 

Keep in mind that any software written before the QMS is in place must be handled as SOUP (Software of Unknown Provenance), or reintegrated manually into the quality-controlled product with appropriate traceability. Both options can be painful! 

2. Clear Requirements and Project Structure

Successful medical device software projects start with crystal-clear requirements and well-defined project parameters. Those requirements need to be written to provide direct traceability from user needs through to the validation and verification performed on them. 

User Requirements Documentation: IEC 62304 does not require you to use a waterfall development model, nor does it insist that you document every requirement in detail before you start coding. However, even if you are using an iterative development approach, you must ensure that the requirements for each feature are clearly defined before you begin implementing it.
If requirements are vague or inconsistent, it will be difficult to maintain traceability and this can lead to costly rework. Requirements should cover all key areas: functional requirements (what the software does), non-functional requirements (such as performance, security, and scalability), user requirements (how users interact with the system), and quality requirements (including reliability and safety). These requirements provide the foundation for all further development and testing activities. 

User Types Defined: Medical device software often serves multiple user types – from patients and caregivers to healthcare professionals and technicians. Each user type has different needs, skill levels, and contexts of use. Documenting these user types and their specific requirements ensures your software design meets real-world needs and regulatory expectations for usability and safety. 

Project Goals Established: Clear project goals aren’t just about knowing what you’re building – they’re about understanding why you’re building it and how success will be measured. Define your key deliverables, project milestones, and success criteria upfront. This clarity helps everyone make informed decisions when trade-offs inevitably arise during development. It also helps to get all essential stakeholders involved early in the process to ensure alignment (do we all agree on what this product should do?) and get their buy-in (are we all invested in the success of this product?). 

3. Risk Management and Documentation Framework

Medical device development is fundamentally about managing risk, and this starts before any code is written. 

Risk Register Started: Risk management isn’t something you bolt on at the end – it’s woven throughout the entire development process. Your initial Risk Register should identify potential hazards, assess their likelihood and severity, and define mitigation strategies. This living document will evolve throughout development, but having a solid foundation helps guide early architectural decisions and testing strategies. 

Regulatory approaches to medical software that includes AI are constantly evolving. Talk to us to get support on where AI fits in your product, and how to develop it in a compliant way. 

Documentation Responsibilities: Understanding who’s responsible for what documentation prevents gaps and overlaps that can derail regulatory submissions. Your team needs appropriate templates for design specifications, test protocols, validation reports, and user documentation.

4. Development Process and Team Structure

Clear processes and defined roles prevent confusion and ensure quality throughout development. 

Code Development Process Defined: Before coding begins, establish your development methodology, code review processes, repository management, and approval workflows. Will you use agile methodologies following AAMI TIR45 guidance? How will you manage version control and releases? What testing will occur at each stage? These decisions shape everything from team collaboration to regulatory compliance. Firefinch has standard development processes which are compatible with regulatory requirements. 

Client-Side Role Distribution: Successful medical device software projects require clear roles and reliable communication channels. Key roles should include a Product Owner who understands both business and technical requirements, a Quality Representative who ensures compliance, and Domain Experts who understand the clinical context. Each role needs clearly defined responsibilities and reliable contact points to prevent project delays. 

Communication Plan Established: Regular, structured communication between all stakeholders prevents misunderstandings and keeps projects on track. Establish clear routes between Project Managers and Product Owners, define meeting cadences, and agree on reporting formats. This seems basic, but poor communication is responsible for many project failures. 

5. Testing and Validation Strategy

Testing isn’t something that happens at the end – it’s planned from the beginning. 

Testing Strategy Defined: Your testing approach must align with your device’s safety classification and regulatory requirements. This includes unit testing during development, integration testing as components come together, system testing of the complete software, and user acceptance testing in realistic conditions. The strategy should also address how you’ll validate that user requirements are met and verify that product specifications are achieved. 

For medical device software, testing goes beyond functional verification – it includes safety testing, usability testing, and validation in clinical contexts. Plan these activities early so they’re integrated into development timelines rather than creating bottlenecks later. Consider also cybersecurity and penetration testing if applicable (for example, UL-2900-2-1).

Your Partner in Preparation

Getting ready for medical device software development can feel overwhelming, especially when you’re eager to start building. The good news is that you don’t have to navigate this alone. At Firefinch, we’re not just your development partner – we’re your guide through the entire process. 

We regularly help clients establish Quality Management Systems, connect them with regulatory experts, facilitate requirements workshops, and set up development frameworks that meet medical device standards. Our experience means we can often accelerate this preparation phase while ensuring nothing important is missed. 

Remember, time invested in proper preparation pays dividends throughout development. Projects that start with solid foundations move faster, encounter fewer obstacles, and reach market more efficiently. Those who rush into coding without adequate preparation often find themselves rebuilding systems, repeating validation work, or facing regulatory delays that could have been avoided. 

Your revolutionary medical device deserves software that’s built right the first time. Let’s make sure you’re ready to succeed. 

💬 Ready to discuss your project preparation? Book a friendly, no-obligation chat with our team to review your readiness checklist and explore how we can support your journey to market. Contact us for further information.

🖱️ Firefinch specialises in compliant medical device software development with deep expertise in regulatory requirements, quality systems, and development best practices.