Our QMS Development & Implementation services provide comprehensive support for establishing, upgrading, or remediating Quality Management Systems that are fully aligned with global medical device regulations. We specialize in designing compliant systems tailored to your organization’s size, product risk classification, and operational structure—whether you’re a startup preparing for your first product launch or a global manufacturer scaling into new markets.

Key Services:

Custom QMS Design & Deployment
We develop a modular QMS framework that integrates seamlessly with your existing processes and business model.

Global Regulatory Alignment
We ensure your QMS meets the requirements of EU MDR/IVDR and MDSAP jurisdictions. Our approach supports harmonization across markets, reducing complexity and compliance risk for global operations.

Process Development & Optimization
From design controls and risk management to supplier quality and post-market surveillance, we help you establish efficient, compliant, and audit-ready processes that enable continuous improvement and reduce the cost of quality.

With deep industry knowledge and regulatory expertise, we don’t just build QMS documentation—we create sustainable quality systems that serve as a competitive advantage. Our goal is to embed compliance into your operations in a way that enhances performance, supports innovation, and ensures long-term regulatory success.

Regulatory compliance doesn't happen by chance—it’s the result of rigorous preparation, aligned systems, and a culture of accountability. Our Internal Audit, Supplier Audit and Audit Readiness services ensure that your organization and partners are fully prepared to meet the expectations of global regulators, notified bodies, and customers.

We provide:

Internal Audit Services: Risk-based audits aligned with ISO 13485, FDA QSR, MDSAP, MDR/IVDR, and other relevant standards to assess the health of your quality system and drive continuous improvement.

Supplier Audit, Qualification & Oversight: Evaluation, audit, and development of critical suppliers to ensure regulatory compliance and supply chain integrity.

Audit Readiness & Mock Inspections: Simulated audits and readiness assessments to prepare your team for regulatory, notified body, and customer inspections—with tailored training, documentation reviews, and coaching.

With experience on both sides of the audit table, we help you identify gaps before they become findings—minimizing risk, building confidence, and ensuring your organization is always inspection-ready.

Transitioning from a paper-based or hybrid quality system to an electronic Quality Management System (eQMS) is a critical step in modernizing compliance operations, improving efficiency, and scaling with organizational growth. Our Digital QMS Transition Support service provides expert guidance throughout the entire lifecycle of eQMS implementation—ensuring a smooth, compliant, and value-driven transformation.

Key Service Elements:

Needs Assessment & Platform Selection: We begin by conducting a detailed assessment of your current QMS processes, regulatory obligations, and operational needs.

Implementation Planning & Project Management: We support project planning, resource allocation and process mapping to align existing workflows with the eQMS configuration using a risk based approach.

System Configuration & Process Integration: We work with your team and vendor to ensure that QMS processes are properly configured, including user roles, access levels, and approval workflows

Data Migration & Validation: To ensure continuity and compliance by developing a migration strategy for transferring legacy documents, records, and quality data into the new system.  We establish validation protocols in line with FDA 21 CFR Part 11 and GAMP 5 guidance

Training & Go-Live Support: We deliver comprehensive training tailored to different user groups (administrators, quality team, general users) to ensure adoption and correct system use.

Our approach balances regulatory compliance, operational efficiency, and business scalability. Whether you're moving from spreadsheets or replacing a legacy eQMS, we provide the strategic insight and hands-on support needed to make your digital transition successful and sustainable.

Ongoing Compliance & Maintenance

Maintaining a compliant and effective Quality Management System (QMS) requires more than initial implementation—it demands continuous oversight, proactive improvement, and readiness for regulatory scrutiny at any time. Our Ongoing Compliance & Maintenance service is designed to help medical device companies sustain the health of their QMS, stay ahead of evolving regulatory expectations, and remain inspection-ready across all markets.

Key Service Components:

Management Review Facilitation: We support the planning and execution of effective management reviews that meet regulatory requirements and drive real decision-making.

Quality Metrics & Performance Monitoring: We help you define and track meaningful key performance indicators (KPIs) to measure QMS effectiveness.

Continuous Improvement Initiatives:Beyond compliance, we help you embed a culture of quality and continuous improvement

Regulatory Intelligence & Change Management: We monitor changes in global regulatory requirements (e.g., updates to ISO standards, MDR guidance, FDA regulations) and help you assess the impact of regulatory updates on your QMS and revise affected procedures and documentation

With our ongoing support, you can ensure that your QMS remains not only compliant—but also a strategic, efficient, and resilient system that grows with your business and withstands regulator scrutiny. We help you move from reactive compliance to proactive quality leadership.