Quality for software that patients depend on
Medical and life sciences quality infrastructure is for teams building medical devices, software as a medical device, diagnostics, and therapeutics under FDA and EU MDR oversight. TestLauncher unifies agentic testing, continuous compliance, and an owned QA Brain, so verification is reproducible, evidence is audit-ready, and patient risk is driven down by design.
What makes quality hard in medical & life sciences
Risk that reaches the patient
Hazard analysis is not a paperwork exercise here — every requirement traces to a way the device can harm someone. Coverage has to reach the failure modes that occur once in ten thousand uses, because that instance is a person.
Verification that must be reproducible
Regulators expect that a result can be reproduced and defended years later. Ad hoc test runs are not evidence; you need deterministic execution and records that hold up under audit and litigation.
Software that changes faster than filings
SaMD and connected devices ship updates continuously, but each change can invalidate a prior validation. Regression and impact analysis have to keep pace without breaking the locked-down state a clearance depends on.
A decade-long design history to defend
The design history file and post-market record must stay coherent across device generations and departing engineers. When a field issue surfaces, the reasoning behind every control has to still be retrievable.
One intelligence layer for medical & life sciences
The same owned QA Brain — testing, knowledge, and compliance — focused on the risks this sector can’t afford to get wrong.
bugAgent
Scriptless suites that self-adapt across firmware and app releases, exercising alarm conditions, dosing limits, and failure modes autonomously — surfacing hazards before verification sign-off, not after a field complaint.
ARC
GAMP 5 and CSV-aligned validation and audit trails generated continuously, so design history and verification evidence accumulate as a byproduct of the work rather than a pre-submission scramble.
qualThread
The digital thread linking user needs to design inputs, risk controls, and test results — living traceability that survives device iterations, staff turnover, and a decade of post-market surveillance.
manualTesting
Expert human testers for clinical-context edge cases, usability under stress, and real-world judgment that automation cannot supply — the human-in-the-loop a patient-safety claim depends on.
Designed to support the regimes you work toward
TestLauncher is designed to support programs working toward the standards below and generates the traceability and evidence they call for. Naming a standard here is not a claim of certification — it describes the regimes our customers operate in.
- FDA 21 CFR Part 820
The US Quality System Regulation for medical devices, intended to govern design controls, verification, and production quality.
- EU MDR 2017/745
The European Medical Device Regulation, which sets safety, clinical evidence, and post-market surveillance expectations for devices sold in the EU.
- IEC 62304
A widely recognized standard for the medical device software lifecycle, covering development, maintenance, and risk management activities.
- ISO 14971
The reference framework for applying risk management to medical devices across their lifecycle.
- ISO 13485
A quality management system standard for medical device organizations, commonly used to demonstrate regulatory readiness.
Bring the QA Brain to medical & life sciences.
Powered by bugAgent, ARC, qualThread, manualTesting. Tell us where quality can’t fail and we’ll show you what an owned intelligence layer looks like for your programs.