Select a Region North America

Quality Assurance/Quality Management Systems

An Evolving Global Industry Requires a Dynamic Approach

The life sciences industry has increased its demand for more robust, harmonized quality systems and experienced talent who know the evolving regulatory requirements. With the continual evolution of national and international regulations, manufacturers face significant challenges to keep up and comply. The importance of compliance is not only to ensure a quality product. It’s also crucial because the cost of noncompliance is high: rejected product, delays to commercialization, product recall, product complaints, adverse events and/or agency action. Our Quality Compliance team is prepared for the challenge.

EVERSANA’s Quality Compliance Solution

EVERSANA’s Quality Compliance provides a holistic lens across the product life cycle. Our team understands that an effective and efficient Quality System is critical to successfully launch a global product that meets all regulatory compliance regulations. With over 100 years of combined industry experience, our team brings an unrivaled level of expertise in quality and regulatory compliance consulting, Quality System outsourcing, quality management systems, document control, and training management within the medical device, pharmaceutical, tissue, donor eligibility, and other regulated spaces. For a complete view of our experience across these services, visit

Connectivity Across the Life Cycle

Through the integration of internal data, external data and real-world evidence (RWE), combined with advanced analytics, our Quality Compliance team provides a predictive and proactive approach to insights that allows us to deliver continuous readiness models for regulatory inspections that are more cost efficient. The team is built with enhanced flexibility in mind and delivers ROI operational efficiencies, quality reputation and competitive advantages.

Extensive Portfolio of Offerings

Quality Compliance Services

Quality Systems

  • Quality Management System (QMS) design, development, implementation, execution and optimization
  • eQMS solutions – document management, training, design control, complaint handling, supplier management, and more
  • CAPA planning and execution
  • Complaint management

Design Control Execution Support

  • Design and development planning, design input, design output, design review, design verification and validation, design transfer, design history file (DHF) – 21 CFR 820, ISO 13485
  • Risk management and risk analysis – ISO 14971
  • Embedded (SiMD) and stand-alone (SaMD) software – IEC 62304
  • Medical electrical equipment – IEC 60601
  • Human factors and usability engineering – IEC 62366

Process Optimization, Verification and Validation

  • Lean manufacturing and Six Sigma optimization
  • Gemba value stream mapping
  • Implementation of manufacturing and supply
  • Manufacturing and Quality System software
  • Sterilization validation
  • EtO, gamma, electron beam, moist heat
  • Process analysis and process validation (systems, equipment, test methods, etc.)
  • Software validation (product and non-product)
  • Cleaning and packaging validation

Didactic Training Sessions

  • Quality Systems (FDA, EU, MDSAP), design control and risk management, verification and validation, CAPA handling, regulatory inspections, 21 CFR Part 11 combination products (21 CFR Part 4), etc.

Quality Solutions

  • Quality support/readiness for regulatory submissions (510(k), PMA, EU, BLA, IMPD, NDA, ANDA, etc.)
  • Data integrity solutions
  • Supplier selection/selection strategy/contract negotiation support
  • Quality Technical Agreements
  • GxP business transformation and optimization

Regulatory Compliance

View an extensive list of EVERSANA’s Regulatory Consulting Services, click here.

Gap Assessments

  • Quality Systems, 21 CFR Part 11, product design and development (incl. software), CAP and CLIA


  • Documentation preparation
  • Quality System, product DHF/medical device file/technical file compliance
  • Product recall; corrective action strategy and execution
  • Agency enforcement assistance
  • Agency response support
  • CAPA planning and management

Due Diligence Assessments

  • Quality System; product design and development
  • Acquisitions and mergers

Mock Audits/Inspections

  • FDA, MDSAP, ISO 13485, EU MDR 2017/745 / EU IVDR 2017/746

Inspection/Audit Management and Support

  • Facility/systems inspection readiness
  • FDA inspections
  • ISO 13485 & MDSAP audits

General Auditing

  • Supplier quality (full program or single audit)
  • Internal audit (full program or single audit)
  • Corporate audit
  • Manufacturing process/facility review

Explore EVERSANA's Quality Compliance Experts' Thought Leadesrhip.

Contact Us

Ready to learn more?

Schedule a meeting today.