What Makes a Software Company Qualified for IEC 62304?

When you're developing regulated medical device software, choosing the right development partner can determine whether your product reaches market on time or gets stuck in regulatory limbo. IEC 62304 compliance isn't just a checkbox; it's a comprehensive framework that governs the entire software lifecycle for medical devices. But what separates a truly qualified IEC 62304 software development company from one that simply claims expertise?

If you're a MedTech founder or product manager evaluating potential partners for your FDA-compliant software development project, understanding these qualifications is critical. The wrong choice can lead to costly rework, regulatory delays, or even product recalls.

Understanding IEC 62304 and Its Role in Medical Device Software

IEC 62304 is the international standard for medical device software lifecycle processes. It applies to software that is itself a medical device (Software as a Medical Device, or SaMD) and to software that is an embedded or integral part of a medical device.

The standard covers everything from initial concept through development, testing, deployment, maintenance, and eventual retirement. For Class II medical device software and higher-risk products, compliance isn't optional, it's a regulatory requirement enforced by the FDA, European Notified Bodies, and other global authorities.

Key aspects of IEC 62304 include:

Risk-based software classification (Class A, B, or C)
Comprehensive software development planning
Requirements management and traceability
Architecture and detailed design documentation
Unit, integration, and system testing
Risk management integration per ISO 14971
Configuration management and version control
Problem resolution and maintenance processes

A qualified SaMD development company must demonstrate not just theoretical knowledge of these requirements, but practical experience implementing them across multiple projects.

Core Qualifications: What to Look For

1. Proven Experience with Regulated Software Lifecycles

The most important qualification is demonstrated experience delivering FDA-compliant software development projects from concept through regulatory clearance.

Look for companies that can provide:

Case studies showing successful 510(k) submissions or CE Mark certifications for software products
References from MedTech clients who can speak to their regulatory expertise
Portfolio diversity across different device classifications and therapeutic areas

A company that has only worked on Class I devices may not have the depth needed for your Class II medical device software project. Similarly, experience with pharmaceutical applications doesn't automatically translate to medical device expertise.

2. Quality Management System (ISO 13485)

Any serious medical device software development partner should operate under a Quality Management System (QMS) that follows ISO 13485. This demonstrates that the company has established processes for:

Document control and record management
Design controls and design history files
Supplier management
Corrective and preventive actions (CAPA)
Internal audits and management review

Your development partner's QMS becomes an extension of your own regulatory framework. Their documentation, testing records, and traceability matrices will likely be reviewed during your own regulatory audits.

Important question to ask: Can they provide you with their ISO 13485 SOPs and explain how their QMS integrates with IEC 62304 requirements?

3. Deep Knowledge of Risk Management Integration

IEC 62304 doesn't exist in isolation, it requires tight integration with ISO 14971 (risk management for medical devices). A qualified company must demonstrate expertise in:

Conducting software hazard analysis
Implementing risk control measures in code
Maintaining software risk management files
Updating risk analysis throughout the lifecycle
Verifying risk control effectiveness

The relationship between software architecture decisions and risk mitigation is critical. For example, choosing to implement certain safety features, adding redundancy, or implementing specific data validation routines should be directly traceable to identified hazards and risk controls.

4. Comprehensive Testing and Validation Capabilities

Testing for medical device software goes far beyond typical commercial software QA. A qualified partner must have:

Structured testing processes including:

Unit testing with documented test cases and coverage metrics
Integration testing with clear test protocols
System testing aligned with software requirements
Regression testing for all modifications
Usability testing per IEC 62366 (human factors)

Validation expertise for:

Software of Unknown Provenance (SOUP) / Off-The-Shelf (OTS) software evaluation
Cybersecurity validation per FDA guidance
Performance testing under specified conditions
Data integrity and accuracy verification

For Class II and Class III devices, software validation isn't just about proving the code works, it's about creating objective evidence that the software consistently produces results meeting predetermined specifications.

5. Agile Experience Within Regulatory Constraints

Modern medical device development increasingly adopts Agile methodologies, but implementing Agile in a regulated environment requires special expertise. The AAMI TIR45 guidance document provides a framework for using Agile approaches while maintaining IEC 62304 compliance.

A qualified SaMD development company should be able to explain how they maintain traceability in iterative development cycles, ensuring that every user story and sprint deliverable maps back to formal requirements and risk controls. They need to demonstrate how they handle requirements changes without compromising documentation integrity, often through controlled change management processes that update traceability matrices and risk analyses in real-time.

The right partner will show you how they integrate testing into sprints while maintaining validation rigor, conducting unit and integration testing within each sprint while reserving formal validation activities for appropriate milestones. They must balance velocity with documentation requirements, producing "just enough" documentation during development while ensuring all regulatory artifacts are complete before submission. Finally, they should conduct design reviews and risk assessments in an Agile cadence, embedding quality gates and risk evaluations into sprint reviews rather than treating them as separate waterfall-style phase gates.

Red flag: A company that claims "pure Agile" or dismisses documentation as "waterfall thinking" likely doesn't understand regulatory requirements. The right approach balances agility with necessary rigor.

6. Regulatory Documentation Expertise

One of the most overlooked yet essential qualifications when evaluating a development partner is their ability to deliver the rigorous documentation required for regulatory submissions. Regulatory compliance doesn’t just hinge on great technology, it depends on clear, orderly, and comprehensive documentation. That’s why choosing a partner with experience in regulatory submissions can make the difference between a smooth approval and costly delays.

When developing software for clients preparing for an FDA submission, our team provides a detailed documentation package tailored to regulatory expectations. This includes:

Software documentation including:

Software Description
Risk Management File
Software Requirements Specification (SRS)
System and Software Architecture Design
Software Design Specification (SDS)
Traceability Matrix
Software Development, Configuration, Management, and Maintenance Practices
SOUP
Software Testing as Part of Verification and Validation
Software Version History
Unresolved Software Anomalies

Integration with your DHF: These documents must integrate seamlessly with your Design History File (DHF) for submission to the FDA or Notified Bodies. A qualified company knows exactly what regulators expect and creates documentation that withstands scrutiny.

7. Cybersecurity and Data Privacy Competence

While secure software development isn’t an explicit requirement under IEC 62304, it has become a non-negotiable for devices destined for FDA submission. The FDA’s current stance makes demonstrated cybersecurity expertise essential, manufacturers must now provide extensive documentation outlining their security practices and show how cybersecurity has been addressed throughout the product lifecycle. Look for:

Experience with FDA premarket cybersecurity guidance
Threat modeling and vulnerability assessment capabilities
Secure coding practices and code review processes
Penetration testing for connected devices

8. Post-Market Support and Maintenance Capabilities

IEC 62304 compliance doesn't end at product launch. The standard requires ongoing maintenance activities including:

Problem reporting and analysis
Software updates and patches
Regression testing for modifications
Updated risk analysis for changes
Documentation updates

A qualified partner should offer post-market support that maintains compliance throughout your product's lifecycle. Ask about their processes for handling bug reports, security vulnerabilities, and feature enhancements in a regulated environment.

Evaluating Potential Partners: Key Questions to Ask

When interviewing potential development partners, use these questions to separate truly qualified companies from those with surface-level knowledge:

Experience and track record:

Can you provide references from clients who achieved regulatory clearance?
What device classifications have you worked with?
Have you worked with our target regulatory bodies (FDA, MDR, PMDA)?

Process and infrastructure:

Walk me through your software development lifecycle for a typical Class II medical device software project.
How do you integrate risk management activities with development sprints?
What tools do you use for requirements traceability and configuration management?
How do you handle SOUP/OTS software validation?

Team qualifications:

What regulatory training do your developers and QA engineers receive?
Who on your team has direct experience with regulatory submissions?
Do you have dedicated quality and regulatory affairs professionals?

Documentation and deliverables:

What format and tools do you use for regulatory documentation?
How do you ensure documentation stays current throughout the project?

Red Flags to Watch For

Be wary of companies that:

Cannot provide concrete examples of IEC 62304 projects they've completed
Suggest shortcuts or ways to "minimize" regulatory documentation
Don't follow ISO 13485 or can't explain their QMS
Focus primarily on speed and cost without discussing compliance
Lack dedicated quality or regulatory affairs resources
Seem unfamiliar with recent FDA guidance documents
Promise "full compliance" without understanding your specific device classification and risks

Making the Right Choice for Your Medical Device Software Development

Selecting a qualified partner for your IEC 62304 software lifecycle project is one of the most important decisions you'll make as a MedTech founder or product manager. The right partner brings more than just coding skills, they bring regulatory intelligence, quality management expertise, and the documentation rigor required for successful FDA submissions.

The best SaMD development companies become true partners in your regulatory journey, helping you navigate complex requirements while maintaining development velocity and managing costs.

As you evaluate potential partners, prioritize proven experience, certifications, and cultural fit over the lowest bid. The cost of choosing an unqualified partner, in terms of delays, rework, and regulatory setbacks far exceeds any initial savings.

Ready to discuss your medical device software development project? Contact our team to learn how we can help you bring your innovative medical device to market faster and with greater regulatory confidence. Our ISO 13485 driven processes and proven track record with FDA submissions make us the partner of choice for MedTech innovators.