Bash Quality Systems provides consulting and contract quality engineering services for medical device companies developing active, software-driven, and AI-enabled products. Engagements range from focused advisory work to embedded quality engineering on active programs.
SaMD and AI/ML Regulatory Strategy
Regulatory strategy and quality system design for Software as a Medical Device and AI/ML-enabled products. This includes IMDRF SaMD categorization; EU AI Act conformity assessment pathway analysis; FDA PCCP framework alignment; IEC 82304 and IEC 62304 lifecycle architecture; and AI/ML-specific risk management (drift, bias, post-market monitoring). We help you build the quality and regulatory infrastructure before you need to defend it.
AI in Regulated Workflows
Practical guidance on deploying AI tools within ISO 13485 and 21 CFR 820 quality systems without creating compliance gaps or data exposure risk. This includes supplier qualification frameworks for AI SaaS tools under ISO 13485 clause 7.4, validation strategy for LLM-assisted processes (distinct from traditional CSV approaches), data classification methodology for determining what information is safe for cloud-based AI tools versus what requires on-premise or self-hosted model deployment, and governance for AI-assisted documentation in design history files, risk management, and CAPA workflows. We help you capture the productivity gains from AI tooling while maintaining the traceability and control your QMS requires.
Risk Management
ISO 14971 risk management program design and implementation, including overhaul of legacy systems. Expertise in fault tree analysis, FMEA, and structured hazard analysis for combination products and complex active systems. For AI/ML products, risk analysis extends to model-specific hazards: drift, bias, dataset representativeness, and output variability across populations.
Quality Management Systems
Design, implementation, and remediation of quality management systems to ISO 13485, FDA 21 CFR 820, EU MDR, and MDSAP requirements. This includes eQMS implementation and SaaS supplier qualification, management review process redesign, and building QMS programs that generate actionable insights rather than compliance theater.
Auditing
Lead auditor services to MDSAP, ISO 13485, ISO 9001, and 21 CFR 820. Multi-site international audit execution, internal audit programs, and supplier qualification audits. Experience includes FDA inspection preparation and BSI surveillance and scope extension audits.
Design Controls and New Product Development
Design History File management, requirements management, verification and validation strategy, and design characterization. Cross-functional engineering integration for active device programs involving mechanical, software, and electrical disciplines. Quality engineering that supports the development timeline rather than gating it.
Software Quality Engineering
IEC 62304 software quality assurance program architecture, including safety classification, V&V planning, anomaly management, SOUP/SBOM governance, and integration of agile development practices per AAMI TIR45. We build the program structure that lets your development team move fast without creating regulatory debt.
Usability Engineering and Human Factors
IEC 62366-1 usability engineering programs from initial concept through summative validation, including function allocation analysis, formative evaluation design, and Annex C (UOUP) compliance documentation. Experience spans complex capital equipment interfaces and clinical user workflows.
Cybersecurity
Cybersecurity threat management in a QMS context, aligned with FDA pre-market and post-market cybersecurity guidance. Assessment methodology for active devices with embedded software and networked connectivity.