About us
QMS Pro Consulting supports medical device and regulated manufacturing organizations in building, strengthening, and sustaining effective Quality Management Systems aligned with global regulatory requirements.
Audit readiness and audit support are at the core of our services. We work closely with executive leadership, quality, and operational teams to prepare organizations for regulatory, notified body, and third-party audits, manage compliance risk, and achieve consistent, inspection-ready performance.
Our consulting services are aligned with FDA 21 CFR 820, ISO 13485, MDSAP, and EU MDR requirements. We take a practical, risk-based, and hands-on approach, ensuring that compliance is not treated as a one-time exercise but embedded into daily operations.
Whether preparing for upcoming audits, supporting on-site or remote audit activities, or addressing audit findings through CAPA, deviation, and nonconformance management, QMS Pro Consulting acts as a trusted partner, helping organizations achieve sustainable compliance, operational efficiency, and patient safety.
Who we are
QMS Pro Consulting was founded by Vlad Cintean, a Quality and Regulatory professional with over 10 years of experience across medical device and regulated manufacturing environments.
Vlad has led and participated in more than 50 internal, supplier, and regulatory audits, including audits aligned with FDA requirements, ISO 13485, and MDSAP. He has supported organizations in building, remediating, and maintaining Quality Management Systems to successfully achieve certification and pass regulatory and third-party inspections.
He is certified as an ISO 13485 and MDSAP Lead Auditor and holds additional qualifications in ISO 14971 risk management and ISO 9001 quality management systems. His background combines strong operational manufacturing experience with deep regulatory and audit expertise.
Working closely with client teams, Vlad delivers practical, business-aligned solutions that reduce compliance risk, improve audit readiness, and support stable, inspection-ready operations while enabling long-term quality and regulatory compliance.
Services
QMS Pro Consulting provides focused, hands-on quality and regulatory support for medical device and regulated manufacturing organizations. Our services are designed to help teams achieve audit readiness, regulatory compliance, and sustainable Quality Management Systems.
End-to-end support for FDA, ISO 13485, MDSAP, and notified body audits. We help organizations prepare with confidence, reduce inspection risk, and respond effectively before, during, and after audits.
Practical support to remediate audit findings and strengthen CAPA and risk management processes. Our focus is on effective root cause analysis, risk-based decisions, and sustainable corrective actions.
Development, remediation, and improvement of Quality Management Systems aligned with FDA, ISO 13485, and EU MDR requirements, designed to withstand audit scrutiny and support business growth.
Support for complaint handling, PMS, and ongoing compliance activities to ensure systems remain robust, compliant, and inspection-ready throughout the product lifecycle.
Risk-based supplier qualification, oversight, and auditing to strengthen supply chain compliance and reduce regulatory and audit exposure.
Targeted training and interim quality leadership to stabilize quality operations, strengthen internal capabilities, and support organizations during audits, remediation, or growth.
Our Approach
At QMS Pro Consulting, our approach is grounded in real-world regulatory, audit, and manufacturing experience. We focus on helping organizations achieve practical, inspection-ready compliance Rather than applying one-size-fits-all templates, we adapt our support to fit your organization, whether you require short-term audit readiness, targeted remediation, interim quality leadership, or ongoing compliance support.
How We Work
Audit-Driven
We design and remediate quality systems with regulatory, notified body, and third-party audit expectations in mind, enabling confident preparation for inspections and audits.
Risk-Based
Our work is guided by risk management principles, prioritizing areas that matter most to regulators, patient safety, and business continuity.
Flexible & Tailored
We tailor our approach to your organization’s size, complexity, and maturity, providing scalable solutions that support both compliance and operational efficiency.
Hands-On & Practical
We work directly with client teams to implement solutions, address gaps, and strengthen processes, focusing on what works in practice, not just on paper.
Sustainable Compliance
We help organizations move from reactive audit preparation toward stable, maintainable, and inspection-ready operations that support long-term compliance and growth.