SaMD and Software Quality Engineer Interview Questions for Medical Devices (With Answers)

Software is now part of most medical devices, and many devices are software alone. Interviewers for software quality, SaMD regulatory and software validation roles want to hear that you can combine agile engineering with regulatory discipline. This guide has 8 model questions with answers and three case studies with ideal answers on hotfixes, vulnerable components and self-updating algorithms.

What to prepare

Know the lifecycle standard IEC 62304, the basics of risk management for software, cybersecurity expectations and the difference between product software and quality-system software. Refresh is my software a medical device, SaMD training, software validation (CSV and CSA), cybersecurity and the SOUP guides, starting with what counts as SOUP.

Eight common questions with model answers

1. What is Software as a Medical Device?

Model answer: “Software intended for a medical purpose that performs that purpose without being part of a hardware medical device. The IMDRF definition is the common reference. It is different from software in a medical device, such as firmware that runs a pump. The regulatory questions begin with intended purpose: what the manufacturer claims the software does.”

2. Explain the IEC 62304 software safety classes.

Model answer: “Class A is where no injury or damage to health is possible, Class B where non-serious injury is possible, and Class C where death or serious injury is possible, judged on the hazardous situations that software can contribute to. The class decides how much process rigour is needed: more documentation, architecture and unit-level verification as the class rises. It is assigned through the risk management process and reviewed when risk changes.”

3. What is SOUP and how do you handle it?

Model answer: “Software of unknown provenance: software item not developed for the device or developed without a documented process that you can show. I list each SOUP item with version and purpose, define functional and performance requirements, assess known anomalies and the supplier, set risk controls and keep it under change control, including monitoring for new vulnerabilities.”

4. How do you validate a tool used in the quality system?

Model answer: “I define intended use, assess the risk if the tool fails, assess the vendor, then choose assurance activities in proportion to risk. High-risk functions get scripted testing; low-risk functions may rely on unscripted testing or vendor evidence. I record what was done and the conclusion, control changes and review periodically. That reflects the risk-based assurance approach that FDA promotes.”

5. What are your cybersecurity expectations for a premarket submission?

Model answer: “A security risk assessment linked to the safety risk file, secure design and architecture, threat modelling, a software bill of materials, testing such as vulnerability scanning and penetration testing, a plan for monitoring and patching vulnerabilities after release, and labelling that tells users what they need. In the US, section 524B of the FD&C Act makes some of this a statutory requirement for cyber devices. In the EU, MDR Annex I and MDCG guidance address it.”

6. How do you control software changes after release?

Model answer: “Through change control with a documented impact assessment: does the change affect safety, performance, intended use, risk controls or regulatory status? I decide the verification and regression testing needed, update the risk file and documentation, and decide whether the change needs a new regulatory submission or notification. Even small patches follow the process, scaled to risk.”

7. How does agile development work in a regulated environment?

Model answer: “Agile practices can work if the evidence is in place: requirements traceable to risks and tests, reviews and approvals recorded, verification complete before release and design records retained. I use sprints for development speed, while the definition of done includes the regulatory records. Automation of traceability and testing helps keep both.”

8. Tell me about a software quality issue you resolved.

Model answer (STAR): “A release shipped with a defect in a dose-calculation display rounding rule (situation). I was asked to run the investigation (task). I traced it to a requirements gap and untested boundary cases, opened a CAPA, added the cases to automated regression tests, and reviewed the risk file for similar functions (action). No further issues occurred and the process change was adopted across teams (result).”

Case study 1: the urgent hotfix

Scenario: A senior developer wants to push a hotfix straight to production, skipping change control, because a customer is affected.

Ideal answer: “I would support speed but not skipping control. If there is a patient safety risk, we can follow an expedited change path: a rapid impact and risk assessment, focused verification of the fix and regression tests on affected areas, approval by a named person, and release. Full documentation is completed straight after, and the event is recorded. I would also check whether the defect is reportable or needs a field action. Skipping the process would make the release unverifiable and could raise a nonconformity at audit.”

Case study 2: a vulnerable open-source library

Scenario: After release, a critical vulnerability is published in an open-source library inside your device software.

Ideal answer: “I would use the software bill of materials to confirm exposure, then assess exploitability in our context and the risk to patient safety, using the risk file. If the risk is not acceptable, we need a fix or compensating control. I would plan the patch through change control, verify it, notify users and regulators where required, and follow the vulnerability management process. I would also review our monitoring so we detect such issues earlier. All decisions are recorded, including a justified decision if the vulnerability is not exploitable.”

Case study 3: a self-updating algorithm

Scenario: The data science team wants the machine learning model in your SaMD to retrain automatically on new patient data.

Ideal answer: “That makes the model a moving target, so the change needs to be planned. I would ask what is allowed to change, how performance is monitored, what the limits are and how updates are verified before release. In the US, FDA’s approach to a predetermined change control plan lets a manufacturer define in advance the modifications and the methods to validate them. In the EU, the rules on significant changes and the notified body’s view apply. Until a plan exists, I would recommend locked versions with controlled, validated updates. Data quality, bias, performance monitoring and labelling should also be addressed.”

Mistakes to avoid

• Saying agile and regulation cannot coexist.
• Describing software validation as running the same heavy scripts for every tool.
• Forgetting that cybersecurity is a safety topic and belongs in the risk file.
• Not knowing your own SOUP or open-source components.

Frequently asked questions

Do I need to be a programmer?

Not always, but you should understand how software is built, tested and released, and be able to read requirements, test reports and traceability matrices.

Which standards should I name?

IEC 62304 for the lifecycle, ISO 14971 for risk, IEC 62366-1 for usability, ISO 13485 for the quality system, and cybersecurity guidance from FDA and MDCG. See also usability engineering.

Where can I read more interview guides?

Start with the validation engineer interview guide and the design controls and risk interview guide.

Model answers are examples; adapt them to your real experience.

Talk to the AptSkill team

Preparing for a software quality or SaMD interview? Send us a message.