Services

Quality System Design and Improvement

Designing a quality system for a company building from the ground up, rebuilding one that has fallen behind, or improving one that already works but should work better. This is the core of what I do, and where deep, hands-on experience produces a system that drives real business improvement and stands up to scrutiny, whether from FDA, another regulator, or a notified body.

Quality System Design and Implementation. Designing and implementing a quality system, or a single element of one, for companies building from the ground up or rebuilding after a setback, architected to be effective, efficient, and compliant from the start.

System Improvement and Gap Assessment. Assessing an existing system against the full set of regulations and standards that apply to you, device or pharmaceutical, then improving the parts that slow you down or create risk.

CAPA Systems. CAPA built to drive real improvement: sound investigation and, above all, a rigorous effectiveness check, the part that matters most. Just as important is the escalation into CAPA from trending, complaints, and nonconformance handling, the point where most systems are weakest.

Complaint Handling and MDR. Complaint processes from intake through investigation, MDR submission where reportable, and closure, then the post-closure trending that drives escalation into CAPA, so the knowledge those complaints hold becomes improvement rather than just a met requirement.

Supplier Controls. Supplier selection, qualification, monitoring, and corrective action that satisfy FDA and notified bodies while reducing risk and strengthening the business.

Risk Management. The risk management system, not the standard behind it, is the heart of a modern QMS, and QMSR renews the focus on integrating it across every element, product-related and administrative alike. Grounded in ISO 14971 and woven through the whole system, it serves the mission we share: effective medical solutions that protect health.

Readiness and Ongoing Support

Inspection Readiness and Mock Inspections. Preparation built on the new QMSR risk-based inspection model, including mock inspections and staff coaching before the investigator arrives.

QMS Auditing and Assessment. Internal audits, audit program design, and full system assessments, including simulated FDA inspections, delivered by an Exemplar Global Certified Lead Quality Management System Auditor.

Interim and Acting Leadership. Stepping into senior quality and regulatory roles on an interim basis, from Director-level Quality, Regulatory Affairs, or Quality Engineering positions to focused leadership of recalls, CAPAs, complaint handling, and similar efforts, wherever you need to cover a gap with a capable quality leader.

Fractional Quality and Compliance Leadership. Ongoing senior leadership or advisory counsel for companies not yet ready for a full-time quality executive.

Custom Training. GMP and quality training built around your own processes and SOPs, so your team learns the regulations and the system they run day to day together, rather than a generic curriculum.

Compliance Response

When FDA attention does arrive, these are the situations that most often fall to a senior consultant, and they sit squarely in my realm.

FDA 483 Response. Structured, defensible responses grounded in real root cause and CAPA commitments FDA will accept, with the agency communication managed throughout.

Recall and Field Action. Recall strategy and field action coordination under 21 CFR 806, including the decisions, execution, and reporting that hold up under FDA scrutiny.

How Training Fits

Custom training, listed above, is a service tailored to your own quality system. Standardized training on the QMSR inspection changes and related topics is offered separately, on demand or as live webinars, for teams that want to build readiness on their own schedule.