Prove your QMS. Before the auditor does.
Simulate FSCA, CAPA and post-market response scenarios under realistic operational pressure.
What if the entire exercise, from scenario to audit-ready report, took less than 60 minutes? You could run it this week.
Mapped to FDA QMSR · EU MDR · ISO 13485 · TGA · and more
Why now
Auditors increasingly test how the system performs under pressure
Regulators and notified bodies want evidence that CAPA, vigilance and FSCA processes work operationally, not just that procedures exist on paper.
Post-market response timelines continue to tighten
Medical device manufacturers face growing pressure to coordinate faster across quality, regulatory and engineering teams during recalls, field actions and safety events.
Modern device risk extends beyond your own walls
Connected devices, third-party software and outsourced manufacturing have expanded the operational perimeter of every medical device company.
The frameworks behind every notified body audit, FDA inspection and market action
Complaints and CAPA anchor in QMSR / ISO 13485 (cl. 8.5.1, 8.5.2). Corrections and removals fall under 21 CFR Part 806; medical device reporting under 21 CFR Part 803; EU vigilance under MDR Articles 87-92. In Australia the Procedure for Recalls, Product Alerts and Product Corrections (PRAC) replaced URPTG on 5 March 2025 and now governs all market actions. UDI traceability is the operational backbone everywhere.
CAPA is the single most-cited Form 483 deficiency. TGA conformity assessment relies on ISO 13485 evidence and the Essential Principles in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002. A risk file update under ISO 14971 must accompany every CAPA.
Section 524B mandates vulnerability management, secure development, SBOM and patch capability for cyber-device premarket submissions. EU MDR Annex I embeds software and cybersecurity expectations in essential requirements. The TGA's Medical Device Cyber Security Guidance for Industry expects manufacturers to maintain an SBOM, monitor for emerging vulnerabilities and demonstrate cyber risk management across the total product lifecycle.
US medical device reporting under Part 803 (30-day clock). EU vigilance under MDR Articles 87-92 on a 2 / 10 / 15-day three-tier. PSURs sit at MDR Article 86; trend reporting at Article 88. In Australia, sponsors report adverse events through the TGA's Incident Reporting and Investigation Scheme (IRIS) on a 48-hour death or serious public health threat / 10-day serious deterioration / 30-day other timeline. Mandatory reporting by healthcare facilities is now also in force.
From scenario to audit-ready report, in under 60 minutes.
Built around your context
Answer a few questions about your setup, including your device class, regulatory regimes, manufacturing footprint and cyber exposure. The scenario is tuned to the obligations actually in scope, not a generic template. Hours of consultant prep, designed in minutes.
Run it live, virtually
Your team joins a video call. QA, RA, Manufacturing, Vigilance Coordinator, Product Security / CISO, Clinical Affairs and senior management observers in the same call; each function makes the decisions they'd actually make. The recording is the evidence stream. Scheduling is the only setup.
The report is ready before you close the call
Results generated in minutes, logged against your internal QMS and what regulators demand. See areas for improvement and re-run quarterly to show the improvement curve auditors and senior management now want to see.
Tailored, not templated
Recall execution under PRAC and Part 806
Customer-reported failure mode triggers a Class 2 market action across AU and US markets. Sponsor notification to TGA, FDA Part 806 reportable correction decision, distributor and end-user comms, retrieval logistics, end-of-quarantine clearance.
Cyber vulnerability disclosure
SBOM-component vulnerability disclosed by upstream supplier. Coordinated disclosure timeline, post-market cyber finding, FDA Section 524B response, TGA cyber-guidance expectations.
Supplier non-conformance triggers batch hold
CDMO process deviation discovered during routine review of supplier records. Quarantine decision, root cause across the supplier boundary, CAPA effectiveness verification, MDR / IRIS reportability assessment.
Be the partner that makes notified body audits feel lighter for your clients.
Run your first medical devices exercise this week.
Sign up, pick a scenario, invite the team. The report is ready before the session ends.