Stepping Into Medical Software: A BA’s Look At Regulations

Business Analyst role in regulatory compliance

The Business Analyst’s Role in Regulatory Compliance is crucial in ensuring that medical software development aligns with legal and safety standards. Since BAs act as a bridge between business stakeholders, development teams, and regulatory bodies, they play a key role in translating complex regulatory requirements into actionable software specifications.

BAs need to familiarize themselves with key regulatory frameworks such as FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304. Their role involves interpreting these regulations and ensuring they are reflected in software requirements. This means identifying which aspects of the software must comply with industry standards and working with regulatory experts to clarify compliance needs.

One of the most important tasks for a BA is gathering and documenting regulatory requirements. These requirements must be clear, traceable, and testable. BAs ensure that regulatory constraints are integrated into product development by documenting functional and non-functional requirements that comply with regulations, ensuring risk management principles (as per ISO 14971) are embedded in requirement definitions, applying regulatory requirements to specific software features, ensuring that all compliance needs are covered.

BAs work closely with Regulatory Affairs and Quality Assurance (QA) teams to ensure compliance throughout the software lifecycle. They facilitate communication between teams by organizing workshops and discussions with regulatory experts to clarify compliance needs, ensuring that requirements meet regulatory guidelines before being passed on to developers, assisting QA teams in defining verification and validation (V&V) activities.

Regulatory bodies require complete traceability of software requirements, design decisions, and testing. BAs are responsible for maintaining a traceability matrix, which links regulatory requirements to specific design elements and test cases. This ensures that every regulatory requirement is accounted for and tested properly. Proper documentation also aids in audits, reducing compliance risks.

Differences between medical and non-medical software development

Medical software is often integrated into life-critical systems, such as pacemakers, insulin pumps, and diagnostic imaging devices. Errors in software functionality can lead to incorrect diagnoses, ineffective treatments, or even life-threatening situations. Regulatory oversight helps mitigate these risks by ensuring rigorous testing, validation, and quality control throughout the software development lifecycle.

Unlike typical software products, medical software must comply with global healthcare regulations and undergo extensive verification and validation. Regulatory oversight requires adherence to standards such as FDA regulations in the U.S., MDR in the EU, and ISO guidelines. These frameworks ensure that medical software meets strict safety and performance criteria, unlike general software development, which follows industry best practices without stringent enforcement. Another key aspect is risk management, where medical software must undergo thorough assessments, such as those outlined in ISO 14971, to identify and mitigate potential hazards. In contrast, non-medical software does not typically require such comprehensive risk evaluation. Additionally, traceability and documentation play a critical role, as every change in medical software must be documented and justified, ensuring a complete record from requirements to implementation, testing, and deployment.

Failure to comply with medical software regulations can have severe consequences. One of the most serious risks is patient harm, where software errors may result in misdiagnoses, incorrect treatments, or failure of critical medical devices. Legal and financial penalties also pose a significant threat, as regulatory bodies can impose fines, mandate product recalls, or even ban non-compliant software, leading to financial losses and reputational damage for companies. Furthermore, without proper regulatory approval, medical software cannot be marketed or sold in key regions such as the U.S. and the EU, effectively barring companies from entering major healthcare markets.

Classification of Medical Software by Regulatory Bodies

U.S. FDA Classification

The FDA classifies Software as a Medical Device (SaMD) and software embedded in medical devices based on risk.

• Class I (Low Risk) – minimal risk to patient safety; often exempt from regulatory premarket approval.

• Class II (Moderate Risk) – higher risk, requiring 510(k) clearance (demonstrating similarity to an existing approved device).

• Class III (High Risk) – highest risk, requiring Premarket Approval (PMA) with extensive clinical evidence.

  
  

European MDR (Medical Device Regulation) Classification

The EU MDR classifies medical software into four categories based on patient risk:

• Class I (Low Risk) – General healthcare and wellness software without critical patient impact.

• Class IIa (Moderate Risk) – Software supporting clinical decisions but not directly diagnosing/treating.

• Class IIb (Higher Risk) – Software influencing critical medical decisions

• Class III (High Risk) – Software making autonomous life-critical decisions

Under MDR, standalone software can be considered a medical device if it meets the definition in Rule 11 of the MDR classification rules.

IEC 62304 Software Safety Classification

IEC 62304 is an international standard defining software development processes for medical devices. It classifies software into three Safety Classes based on risk:

• Class A – No injury or damage possible

• Class B – Potential non-serious injury

• Class C – Potential serious injury or death

Examples of medical software by classification

Software Type	FDA Class	EU MDR Class	IEC 62304 Class	Examples
General Wellness Apps	Class I	Class I	Class A	Fitness tracking apps, step counters, sleep monitors
Hospital Workflow Management	Class I	Class I	Class A	Bed management, appointment scheduling
Electronic Health Records (EHR)	Class I / II	Class I / IIa	Class A / B	EMR/EHR systems like Epic, Cerner
Blood Pressure Monitoring Software	Class II	Class IIa	Class B	Apps analyzing BP readings, digital BP cuff software
Glucose Monitoring Apps	Class II	Class IIa	Class B	Apps that display blood sugar levels from a meter
Imaging Analysis Software (Non-Critical)	Class II	Class IIb	Class B	AI-based image enhancement in radiology
ICU Patient Monitoring Software	Class II / III	Class IIb	Class C	Software analyzing patient vitals in real-time
AI-Based Cancer Detection Software	Class III	Class III	Class C	AI systems for tumor detection in CT/MRI scans
Insulin Pump Control Software	Class III	Class III	Class C	Software that directly regulates insulin delivery
Radiotherapy Planning Software	Class III	Class III	Class C	Software calculating radiation doses for cancer treatment

Tools for Structured Requirements Management and Documentation

In medical software development, structured requirements management is crucial due to strict regulatory compliance and risk management needs.

JIRA and the R4J plugin serve as powerful tools for structured requirements management. While JIRA provides a flexible issue-tracking system that allows teams to create, manage, and track requirements within an Agile or traditional development framework, R4J (Requirements for JIRA) is used to enhance its capabilities.

R4J plugin adds hierarchical structuring, traceability, version control, and compliance support, making it suitable for industries with strict regulations. It ensures that every requirement is tracked and verified through the development lifecycle, Regulatory compliance is maintained with traceability and documentation.

Confluence, a collaborative documentation and knowledge management tool developed by Atlassian, provides powerful JIRA integration macros that allow teams to export, display, and manage JIRA data dynamically within Confluence pages. This is especially useful for requirements management, traceability reports, and compliance documentation in regulated industries.

Final thoughts

Regulatory compliance is not just a legal requirement—it is essential for ensuring patient safety and maintaining trust in medical technology. Business Analysts serve as a key link between regulatory bodies, development teams, and quality assurance, ensuring that software meets strict compliance standards. By leveraging structured requirements management, traceability, and risk assessment tools like JIRA, R4J, and Confluence, BAs help streamline compliance processes and reduce risks. Successful collaboration with Regulatory Affairs, Quality Assurance, Risk Management, and Development Teams is crucial in maintaining compliance throughout the software lifecycle. As regulations continue to evolve, BAs must stay informed and proactive, ensuring that medical software remains both innovative and safe for patients worldwide.

About author:

My name is Iryna Sizikova.

For the past 17 years I have been working in the healthcare industry, at Dentsply Sirona, US dental equipment and software product manufacturer that markets its products in over 120 countries.

My current role is the Chapter Lead of the System Analysis and Documentation team.

I am passionate about business analysis and enjoy sharing best practices and techniques with my colleagues. We regularly hold BA club meetings where we discuss challenging topics and explore solutions together.