WELCOME TO QMSPro
Independent Quality & Regulatory Consulting for Medical Device Companies
QMSPro supports medical device and IVD companies with FDA, MDSAP, and ISO 13485 compliance, specializing in audits, inspection readiness, and Quality Management System implementation.
We help organizations prepare for regulatory inspections, manage compliance risk, and implement effective Quality Management Systems. In close collaboration with executive and quality leadership, we provide consulting services aligned with FDA 21 CFR 820, MDSAP, and ISO 13485 requirements.
About us
At QMSPRO, quality is at the heart of everything we do. We are a results-driven consultancy dedicated to helping organisations build, strengthen, and sustain robust Quality Management Systems that meet the highest regulatory and industry standards. With deep expertise in quality assurance, regulatory compliance, and audit readiness, we deliver tailored, practical solutions that align with each client’s business model, products, and stage of growth.
Our flexible, hands-on approach ensures that organisations not only comply with requirements such as FDA 21 CFR 820, ISO 13485, and EU MDR, but also embed continuous improvement into their daily operations. Whether preparing for regulatory or third-party audits, optimizing CAPA and deviation processes, or managing nonconformities, QMSPRO acts as a trusted partner, helping teams achieve sustainable compliance, operational efficiency, and long-term success.
Who we are
Vlad Cintean, founder of QMSPro Consulting, is a quality management and regulatory consultant with nearly a decade of experience in the medical device and diagnostics industry. With a deep understanding of global quality and regulatory standards and a strong focus on practical, effective compliance, Vlad supports companies of all sizes, from early-stage startups to global manufacturers, in building, auditing, and improving Quality Management Systems that enable growth while protecting patient safety.
QMS Implementation: Designs, implements, and optimizes Quality Management Systems aligned with ISO 13485, FDA 21 CFR 820, MDR, and IVDR requirements, ensuring systems are audit-ready while remaining practical and scalable for day-to-day operations.
Audits and Audit Readiness: As an MDSAP Lead Auditor, Vlad conducts and supports internal audits, supplier audits, and gap assessments, and prepares organizations for MDSAP audits, FDA inspections, and Notified Body audits. His audit-driven approach helps teams clearly understand compliance expectations, address gaps efficiently, and achieve successful audit outcomes with zero or minimal non-conformities.
CAPA and Supplier Management: Develops robust CAPA frameworks and supplier quality systems that reduce recurring issues, improve root cause effectiveness, strengthen supplier relationships, and drive sustainable continuous improvement.
Process Optimization: Implements and improves electronic QMS (eQMS) solutions and workflows that enhance efficiency, traceability, and alignment between regulatory requirements, quality objectives, and business goals.
Vlad’s engineering background, combined with Lead Auditor certifications in ISO 13485 and MDSAP, along with certifications in ISO 14971 risk management and ISO 9001, ensures a balanced, hands-on approach to quality, audits, and regulatory compliance.He has held senior quality leadership roles across Europe, leading audit programs and compliance initiatives that improve regulatory readiness while maintaining operational flexibility.
The consulting approach offered is collaborative, transparent, and solutions-focused. He works closely with client teams to perform meaningful audits, strengthen quality systems, and build long-term compliance strategies that support innovation, build trust with regulators and customers, and enable sustainable growth.
