Pragmatic

Agile

Risk-based

Transformative

Pragmatic Agile Risk-based Transformative

consulting

Innovation doesn’t wait - and neither should your compliance strategy.

VectorSpring Advisory combines deep quality and regulatory expertise with a tech-forward, systems-thinking mindset. Our approach is grounded in first principles, clarity, and speed - made for companies operating at the edge of innovation and shaping tomorrow’s products.

Let's Work together!

WHAT WE OFFER

  • Regulatory Strategy

    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.

  • Quality Systems & Operations

    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.

  • Design Control & Risk Management

    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.

  • Fractional QARA Leadership

    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.

  • Company Trainings

    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

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THE

PHILOSOPHY

Regulation and quality should enable innovation, not restrain it. My philosophy centers on simplifying complexity through risk-based judgement, disciplined thinking, and modular, agile systems that reflect reality. Every decision balances rigor with pragmatism to create strategies and systems that actually work for you.

I’m Erin Gunduz, the founder of VectorSpring Advisory. People would describe me as having that combination of technical depth, practical judgement, and dynamic forward momentum that influences change. If you want someone who is collaborative, pragmatic, and delivering high-impact solutions - we will work together!