Operations Maturity Audit — Medical Devices

What this audit examines in Medical Devices

• Regulatory affairs modernization — the generative submission tooling, technical file infrastructure, and SaMD/PCCP framework that compresses regulatory cycle time and absorbs the AI/ML device complexity.
• QMS and design control modernization — the QSR/QMSR documentation, CAPA, supplier, and complaint-handling infrastructure that turns the QMS from a paper exercise into a managed digital system.
• AI/ML device and SaMD platform — the device-embedded AI, model lifecycle management, clinical validation, and post-market monitoring infrastructure that lets the company ship AI-enabled devices defensibly.
• Post-market surveillance and vigilance platform — the adverse event triage, signal detection, and MDR reporting infrastructure that turns post-market into a real-time safety capability instead of a paperwork burden.