Quality Assurance & Regulatory Affairs Services for Medical Devices, IVDs, Combination Products.
Expert consulting to help medical device companies achieve compliance, accelerate development, and navigate global regulatory pathways with confidence.
At FS QARA Consultancy, we partner with medical device organizations to strengthen their Quality, Regulatory, and Clinical operations with precision, clarity, and speed. From early‑stage development to global market expansion, we help teams navigate EU MDR, FDA, and ISO 13485 requirements — transforming regulatory complexity into a strategic advantage. The consultancy is led by founder Foteini Stroumpouli, a global QA/RA expert with extensive experience guiding Class I–III medical devices, IVDs, and combination products through complex regulatory pathways.
Turning regulatory complexity into strategic advantage.
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.
A Career Built on Global Expertise
With two decades of leadership across Europe, the US, and Asia, Foteini Stroumpouli 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
CE markings
FDA clearances
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.
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.
Ready to Strengthen Your Quality & Regulatory Strategy?
FS QARA Consultancy provides expert Quality Management Systems (QMS) development, Regulatory Affairs support, Audit Readiness preparation, Training programs, and Technical Documentation services for medical device and IVD companies.
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We design and scale medical device Quality Management Systems that align with ISO 13485, EU MDR, and FDA 21 CFR 820 requirements — ensuring compliance, efficiency, and audit readiness.
What we deliver:
ISO 13485 System Setup, Implementation & Maintenance — end‑to‑end QMS design tailored to your product lifecycle.
EU MDR & FDA 21 CFR 820 Compliance — structured documentation and process alignment for global regulatory success.
MDSAP‑Compliant QMS — integrated frameworks meeting multi‑jurisdictional standards.
Gap Assessments & Audit Readiness — identify compliance gaps and strengthen inspection preparedness.
Help with the selection of the certification body and lead the negotiations.
QMS remediation plans and execution.
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Navigate global regulatory pathways with clarity and confidence. We support medical device and IVD companies in achieving compliance and market access across the EU, US, and international markets.
What we deliver:
CE marking and FDA submissions:
Preparation and coordination of CE marking submissions under EU MDR
FDA 510(k), De Novo, and pre‑submission support
Regulatory gap assessments to identify compliance risks early.
Regulatory affairs and PMS strategy to successfully enter EU, US and international markets.
Guidance on selecting and engaging with the right Notified Body for your device and regulatory pathway
Prepare regulatory submission packages for CE marking and clearance in the US.
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Ensure inspection readiness and clinical compliance across markets. We help teams prepare confidently for notified body audits, FDA inspections, and internal quality reviews — with precision, clarity, and speed. What we deliver:
Regulatory compliance strategy and documentation alignment:
End‑to‑end review of QMS documentation for EU MDR, IVDR, FDA 21 CFR 820/QMSR, and ISO 13485
Alignment of technical documentation, risk files, and clinical evidence with regulatory expectations
Audit preparation and mock inspections:
Full mock audits simulating Notified Body and FDA inspection conditions
Identification of gaps, weaknesses, and high‑risk areas before the real inspection
CAPA and risk management integration:
Strengthening CAPA processes to meet FDA and MDR expectations
Integration of risk management (ISO 14971) into QMS and audit‑critical workflows
Inspection coaching and post‑audit action plans:
Coaching for SMEs and leadership teams on how to respond during audits
Structured remediation plans to address audit findings and prevent recurrence
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Empower your teams with targeted, practical training programs.
What we deliver:
Custom workshops on EU MDR, FDA 21 CFR 820, ISO 13485:
Tailored training sessions for teams at all maturity levels
Practical interpretation of regulatory requirements
Hands‑on exercises to strengthen QMS and documentation practices
Audit and inspection readiness training:
Preparation for Notified Body audits and FDA inspections
Real‑world scenarios, mock interviews, and response coaching
Training aligned with MDR, IVDR, and FDA QMSR expectations
Leadership coaching for QARA professionals
Onboarding programs for QARA professionals
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We specialize in authoring, reviewing, and refining technical documentation that meets the highest standards of regulatory compliance and usability. Whether you are preparing for audits, submissions, or internal alignment, our support ensures your documentation is complete, coherent, and inspection-ready.
What we deliver:
Design and Development Files (DDF):
Structured records that trace your product’s development lifecycle, aligned with ISO 13485 and FDA expectations.
Medical Device File (MDF) Comprehensive documentation packages that define your product’s specifications, manufacturing processes, and quality controls.
Risk Management Files Expertly compiled risk documentation per ISO 14971, including hazard analysis, risk evaluation, and mitigation strategies.
Validation Protocols & Reports
Clear, audit-ready documentation for IQ/OQ/PQ, software validation, and process validation activities.
Labeling & IFU Development Regulatory-compliant Instructions for Use (IFU), labels, and packaging content tailored to your device class and market.
Technical Files & Regulatory Submissions EU MDR Technical Documentation, FDA 510(k) submissions, and global registration dossiers — built for clarity and completeness.
Ready to unlock new possibilities?
Reach out to schedule a consultation and explore how we can accelerate your next milestone.