A well-designed quality management system forms the foundation of your organization's regulatory compliance strategy. Our QMS development approach focuses on creating systems that not only satisfy regulatory requirements but also enhance operational efficiency and product quality. We work closely with your team to understand your unique processes, challenges, and goals, then develop a QMS that supports both compliance and business objectives.
Our QMS development & implementation services include, but are certainly not limited to:
Comprehensive evaluation of existing quality systems against applicable regulations (FDA, ISO, EU MDR) to identify improvement opportunities.
Development of quality system architecture with appropriate subsystems, processes, and documentation structure
Creation of quality manuals, quality system documentation, and supporting procedures.
Hands-on assistance with QMS rollout, including training, process establishment, and change management.
Alignment of quality systems with other business systems for maximum efficiency.
Guidance on selecting and implementing eQMS solutions that meet your organizational needs.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.
