Questions to Ask Your Medical Device Manufacturer About Software Testing

Worried your medical device software could break or change without notice? Ask these questions.

When a device, app, or patch controls medication dosing, monitors a heart rhythm, or shares data with your clinician, you deserve clear answers about safety and software. In 2026, with faster toolchains, new timing-analysis integrations, and ongoing update slip-ups reported in mainstream tech, transparency from manufacturers matters more than ever.

Why this matters now (fast summary)

Software is the new hardware—and that shift changed how devices fail, how they’re updated, and what you should ask. Late 2025 and early 2026 saw two trends that directly affect patients and caregivers:

• Industry moves to strengthen timing and verification tools (for example, vendors announced integrations of advanced timing-analysis tech in January 2026 to better estimate worst-case execution time).
• High-profile update failures in consumer OSes remind us that even large vendors can ship updates that disrupt crucial functionality.

Those headlines show why simple, plain-language questions about verification, software updates, and support should be part of every device discussion with vendors or clinicians.

How to use this guide

This article gives you: a prioritized set of questions to ask, short explanations to help you understand answers, and next steps if a manufacturer's responses are unclear. Bring these questions to appointments or vendor meetings, and print the short checklist near the end.

Top questions to ask first (critical safety and trust)

Start here—these questions address the core risks most patients and caregivers worry about.

• How do you verify the device software is safe before it ships?

  Ask for plain-language descriptions of testing—unit tests, system tests, and clinical simulations. A confident vendor will describe a combination of automated and human-led testing and offer examples of what was tested.

• Do you perform timing analysis or worst-case execution time (WCET) testing?

  Timing matters for devices that act in real time (like pumps or implantables). If they say “yes,” ask what the tests showed and whether they used third-party tools or industry-standard methods.

• How are safety-critical features validated?

  Probe whether alarms, shut-offs, and fallback modes are tested under failure conditions. You want evidence that safety features work when things go wrong.

• How will I be notified about software updates and what they change?

  Look for a clear update policy: notification channels (app push, email), pre-update testing notes, and the ability to delay or opt out—especially for devices where updates affect therapy.

Verification and testing—questions that go deeper

If a vendor answers the basics, dig deeper with these questions that reveal the depth of their processes and transparency.

• Can you share a summary of your test coverage and test reports?

  Manufacturers may not share raw reports for IP reasons, but a high-quality vendor can provide a summary showing what percentage of code is covered by tests and which scenarios were simulated.

• Do you use third-party, accredited tools for verification?

  Third-party tools (including those recently acquired or integrated into verification toolchains) can indicate independent validation of methods—ask which ones.

• How do you test for rare but dangerous edge cases?

  Probe whether they simulate unusual workloads, network loss, low battery, concurrent app usage, and extreme physiological signals. Real-world failures often come from edge cases.

• Are clinical or user tests part of verification?

  Ask how software is validated with actual patients or caregivers. User studies reveal usability or misunderstanding that lab tests miss.

Software updates and post-market safety

Updating software is necessary but risky. These questions help you understand the update lifecycle and your options:

• What is your update schedule—and can my clinician delay an update?

  Routine security patches are common; but for devices delivering therapy, being able to delay a noncritical update until after clinician review is important.

• How do you ensure updates won't break existing features?

  Ask about staged rollouts, canary releases, rollback plans, and testing on representative hardware before wide deployment.

• Do you publicly post release notes and change logs?

  Good vendors publish plain-language release notes that detail changes, fixed issues, and any known limitations after the update.

• What’s your rollback policy if an update causes problems?

  Find out whether they can remotely revert to a prior safe version, and what that process looks like for patients.

Timing analysis, real-time behavior, and why it’s important

Timing analysis determines whether a device can meet deadlines in real-world use. In 2026, more verification tools integrate timing checks to prevent missed actions in safety-critical systems.

• Do you perform timing or latency tests for critical functions?

  If the device delivers time-sensitive therapy, ask whether they measure delays and worst-case execution times and how they mitigate latency spikes.

• How do you test software under load or low-resource conditions?

  Devices often interact with wireless networks, phones, and wearable sensors. Ask how they verify performance when the CPU, memory, or bandwidth is constrained.

• Who validated your timing tools and methods?

  Ask if they used recognized industry tools or peer-reviewed methods. Vendors using modern timing-analysis integrations can sometimes point to independent validations.

Safety certifications and standards

Certifications show adherence to standards but don’t guarantee perfection. Ask about them and how they apply to your device.

• Which safety and quality standards do you follow?

  Look for standards like ISO 13485 (quality), IEC 62304 (medical device software lifecycle), and IEC 60601 (electrical/clinical safety) where applicable.

• Is the device certified by a recognized body?

  Ask for the certification name, scope (software-only or hardware+software), and whether certificates are recent.

• What post-market surveillance do you maintain?

  Regulators increasingly require post-market monitoring. Ask how they collect and act on field data and user-reported issues.

Transparency and documentation you can ask to see

Manufacturers should provide clear information to patients and clinicians. These requests are reasonable and practical.

• Plain-language security and privacy statement—how your data is stored, shared, and protected.
• Update policy—how often, how notified, and whether you can opt out of noncritical updates.
• Basic test summaries—high-level evidence that features were tested, not the full source code.
• Support contacts and escalation path—who to call for urgent device issues and how quickly they respond.

Support, incident response, and accountability

Good support reduces risk. Ask about response times, clinicians’ roles, and how incidents are reported.

• What are your support hours and expected response time?

  For devices affecting therapy, 24/7 support or defined emergency contacts are important. Note expected time-to-resolution for critical incidents.

• How do you coordinate with clinics or hospitals?

  Ask if they have formal processes to notify clinicians when an update or incident affects patients under care.

• Do you report safety incidents to regulators, and how?

  Manufacturers should report serious adverse events. Ask them to explain the process and whether you’ll be informed if your device is affected.

• Can support access device logs or debug info to diagnose issues?

  Log access helps root-cause issues but raises privacy questions—confirm what will be shared and how that data is protected.

Questions focused on caregivers and non-technical family members

These are plain-language versions you can use directly in a conversation.

• “If my phone gets an update, will it stop talking to the device?”
• “How will I know if an update changes how I use the device?”
• “Who do I call if the device behaves strangely after an update?”
• “Can my doctor pause updates for my loved one until they sign off?”

What to expect from good answers

Not every manufacturer will be able to share source code or proprietary details. But a trustworthy response will usually include:

• Clear, plain-language explanations rather than evasive marketing lines.
• Concrete examples of tests run and scenarios covered.
• Policies for updates, rollback, and clinician communication.
• Support hours, escalation paths, and real contact details.

Red flags

• Vague answers like “we test extensively” without detail.
• No clear update notification process or inability to delay noncritical updates.
• Refusal to describe incident reporting or lack of post-market surveillance.
• No assigned support contact or long, undefined resolution times for critical failures.

Practical next steps if answers are unclear or concerning

If a manufacturer's response leaves you uncomfortable, here’s a step-by-step plan you can follow.

1. Ask for answers in writing (email or patient-facing FAQ). Written answers reduce misunderstandings.
2. Bring answers to your clinician—ask the clinical team or biomedical engineering to review them.
3. Request a demonstration or video showing update installation and rollback.
4. Escalate to hospital procurement or patient safety if the device is part of your clinical care and risks aren’t addressed.
5. Report serious unresolved safety concerns to your country’s regulator (for example, the FDA in the United States) and ask your clinician to assist with reporting.

"You don't need to be an engineer to insist on clear answers—ask how the device will protect you and what happens if it doesn't."

Sample script: What to say when you call or visit

Use this short script with vendors or clinicians. Keep it polite and focused:

“Hello—I'm discussing [device name] for [patient name]. Can you explain in plain language how you test the software, how updates are handled, and who I call if something breaks? I'd like written answers and release notes for any future updates.”

A printable checklist (copy this into a note)

• How is the software verified before release? (ask for a summary)
• Do you perform timing/WCET analysis for critical functions?
• Update notification method and schedule
• Rollback policy and staged rollout plan
• Support hours, contact, and expected response times
• Post-market surveillance process and incident reporting
• Data privacy and log access policy
• Plain-language release notes and change logs

Real-world examples that show why these questions matter

Two trends in early 2026 highlight the stakes:

• Industry consolidation of timing-analysis tools (announced integrations in January 2026) shows manufacturers are investing in formal timing verification to avoid missed deadlines in real-time devices. This reduces the risk of therapy misdelivery but only if manufacturers actually apply those tools.
• High-profile consumer OS update problems in early 2026 serve as a reminder: even big vendors can ship updates that cause devices to behave unexpectedly. Medical device vendors should have stronger safeguards and clearer communication than a consumer OS—but you should verify they do.

Future trends to watch (2026 and beyond)

Regulators and vendors are tightening expectations for software transparency and post-market monitoring. Expect to see:

• Greater emphasis on timing-analysis certification for real-time medical software.
• Mandatory, patient-friendly release notes and improved update controls for therapy devices.
• Wider adoption of staged rollouts, automated rollback, and clinician-controlled update opt-outs.

These changes will make your conversations with vendors more productive—vendors who are early adopters of these practices will have clearer policies and stronger support systems.

Final actionable takeaways

• Bring 6–8 of the top questions to your next appointment—prioritize update policy, support contacts, and safety verification.
• Ask for written answers and release notes—you have a right to clear, patient-facing information.
• Get clinicians involved if you’re uncertain—biomedical engineering teams can interpret technical claims.
• Document any odd behavior after updates and report serious problems to your clinician and regulators.

Call to action

Print the checklist above and bring it to your next device appointment. If you’d like a ready-made one-page sheet, sign up on our site to receive a printable Q&A template tailored for caregivers and patients. Don’t accept vague answers—your safety depends on clarity and accountability.

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