Quality and Regulatory Strategy for Active Medical Devices and AI

Hands-on quality engineering and regulatory strategy for SaMD, AI/ML-enabled products, and complex active devices. FDA and EU MDR. Built by a practitioner, not a slideware firm.

Getting an active medical device or AI-enabled product to market means navigating overlapping regulatory frameworks, evolving standards, and the persistent gap between what guidance documents say and how implementation actually works in practice. For SaMD and AI/ML products, the complexity compounds. IEC 62304 software lifecycle requirements intersect with AI-specific risk considerations that ISO 14971 was never written to address directly. The EU AI Act adds a new conformity layer on top of MDR. FDA's PCCP framework is still maturing. And many quality consultancies are still treating these as future problems rather than present ones. If your team is spending more time debating how to document a process than whether the process itself is right, you have a systems design problem, not a documentation problem. Solving it takes systems engineering discipline, not just quality procedures.

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What makes BQS different

Bash Quality Systems is a solo consulting practice, not a staffing firm. You work directly with Eric Bash, a quality and regulatory affairs professional with 15+ years of experience spanning SiMD/SaMD quality systems (IEC 62304, IEC 82304), active electromechanical device development (IEC 60601), human factors engineering (IEC 62366), risk management (ISO 14971), and naval nuclear operations.

Eric holds an MS in Systems Engineering and brings a discipline most quality consultancies don’t: the ability to diagnose whether your quality system problems are actually process design problems, and to fix them at the structural level.

Eric has held quality engineering and management roles at Gilero, TeraRecon, Teleflex, and ConMed, working on products from infusion pumps and electrosurgical generators to AI-powered imaging systems and drug/device combination products.

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Results

Zero observations during an initial FDA inspection BSI scope extension earned for active device and implantable device design and manufacture 80% reduction in management review engineering effort through process redesign 63% improvement in CAPA timeliness Software quality and design quality teams built from inception with IEC 62304-compliant development lifecycles EU MDR Article 120(3) gap analysis completed for an AI SaMD portfolio

Areas of focus

Design controls and new product development SaMD and AI/ML regulatory strategy (EU AI Act, FDA PCCP, IMDRF GMLP, IEC 82304) Quality management systems (ISO 13485, FDA 21 CFR 820, EU MDR, MDSAP) Risk management (ISO 14971, including AI/ML-specific hazard analysis) Software quality engineering (IEC 62304, AAMI TIR45) Usability engineering and human factors (IEC 62366-1, including Annex C / UOUP) Auditing (ISO 13485, ISO 9001, QMSR, MDSAP) AI tools in regulated workflows (supplier qualification, validation strategy, data governance)

Lets Talk

Whether you need a quality system built from the ground up, a regulatory strategy for a novel AI-enabled product, a facility or supplier audit, or someone who can walk into your design review and ask the hard questions, let's talk.
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