Our Story

Strategic Leadership in Quality & Regulatory Affairs

FS QARA Consultancy was founded to elevate how medical device companies navigate compliance, quality, and regulatory complexity. Led by Foteini Stroumpouli — a certified Lead Auditor for ISO 13485, ISO 9001, and ISO 14001, and a seasoned Quality and Regulatory Affairs Executive with over 20 years of experience across Class I–III devices, IVDs and combination devices — the consultancy blends strategic insight with hands‑on execution across Class I–III devices, IVDs, and combination products.

Career Built on Global Expertise

With two decades of quality and regulatory experience across Europe, the US, and Asia, Foteini has built and scaled quality organizations, led successful Notified Body and FDA inspections, and delivered product certifications and registrations across multiple regulatory frameworks, including:

  • EU MDR & IVDR

  • FDA 21 CFR 820 / QMSR

  • ISO 13485

  • MDSAP

Our experience spans startups, scale‑ups, and multinational manufacturers — giving us a rare ability to align business strategy with regulatory expectations while maintaining operational excellence.

What Sets FS QARA Consultancy Apart:

  • Global Regulatory Expertise

Over 20 years of experience navigating diverse regulatory systems and leading high‑stakes audits, submissions, and compliance programs.

  • Tailored, High‑Impact Support

From QMS design to audit readiness, we meet organizations where they are — and elevate them with clarity, structure, and precision.

  • Strategic & Hands‑On Execution

We combine executive‑level insight with practical implementation, ensuring solutions that are both compliant and operationally effective.

  • Inclusive, Modern Leadership

Our brand reflects the clarity, strength, and nuance required to lead in today’s life sciences environment — with a commitment to collaboration, transparency, and continuous improvement.

A promotional image for FS QARA Consultancy featuring a woman in profile on the left, with gold and black graphic elements, a stack of books, a magnifying glass, and icons representing quality management, regulatory affairs, audit readiness, training, and technical documentation at the bottom. The tagline reads "Strategic Leadership in Quality & Regulatory Affairs."

Your Partner in Compliance Excellence

Whether you are preparing for a regulatory submission, scaling your Quality Management System, or seeking strategic QA/RA leadership, FS QARA Consultancy provides the expertise, structure, and guidance to help you move forward with confidence.

We turn regulatory complexity into a competitive advantage — so you can focus on delivering safe, effective, and innovative medical technologies to the world.