HOW WE ADD VALUE

Regulatory strategy designed for execution. I help innovative teams navigate complex and evolving requirements through clear regulatory positioning, product classification, Q-Submission preparation, and Notified Body engagement, always aligning pragmatism with product intent, speed, and business priorities.

Lean, scalable quality systems designed for how teams actually operate. This includes ISO 13485 implementation and optimization, QMS scaling, process mapping and modernization, SOP development and harmonization, supplier controls, and risk-based mock audits to ensure real audit readiness—not just theoretical compliance.

Hands-on support to build, repair, and align end-to-end design control (ISO 13485) and risk management (ISO 14971) frameworks, including software development (ISO 62304), usability engineering (ISO 62366), and verification & validation strategies. This is delivered as clear, audit-ready DHFs and technical files that reflect your real processes.

QA/RA leadership for organizations that need experienced guidance without a full-time hire. This includes regulatory and quality strategy ownership, cross-functional alignment, risk-based decision-making, and executive-level support during critical growth or transition phases. The focus is on momentum, helping teams make informed decisions, move faster, and build sustainable systems.

Engaging, practical, and tailored to your team’s actual challenges. Sessions are interactive, grounded in real scenarios, and aimed at making teams feel capable rather than overwhelmed.

Potential topics: Design controls, risk management, documentation fundamentals, QMS structure, regulatory pathways, audit readiness, cross-functional alignment

Available as: half-day deep dives, full-day workshops, multi-session programs