Quality Engineering and Validation Consulting

  • Overview
  • Services
  • Experts
  • Why Work With NSF?

Medical device companies require successful implementation of quality engineering and validation to ensure products consistently meet customer and patient needs. NSF’s strategic, tactical and technical expertise will help you with program management, quality assurance and regulatory compliance. Our medical devices consulting services assist with product design and development processes, risk management, manufacturing process development, validation and control. Our approach spans the product lifecycle and supports commercialization and sustainability, as well as addresses product issues and remedial actions to ensure continued safety and effectiveness.


Our comprehensive medical devices consulting operations and risk-based services approach focus activities and resources on the deliverables that matter most to your specific requirements. We deliver results by applying efficient and effective best practices in:

Planning and Project Management

  • Prioritize risk factors, business needs and opportunities
  • Develop multi-function integrated plans
  • Outline project/program objectives, requirements and constraints
  • Establish operating mechanisms to drive deliverables, mitigate project risk and define value
  • Deliver consistent communication appropriate to various levels of the organization

Design Control and Product Change Management

  • Create design, development and change management plans
  • Perform design verification and validation
  • Assist and/or lead the software development lifecycle
  • Ensure a robust engineering change management process
  • Address risk management (EN ISO 14971:2012) through planning, analyses, evaluations and controls
  • Develop or remediate risk management files
  • Ensure postmarket risk re-evaluation

Design Transfer

  • Develop device history records (DHRs) and device master records (DMRs)
  • Document and implement change control
  • Provide process and test method characterization
  • Develop and implement validation programs including validation master plans, process validation, test method validation, and software and automated systems validation
  • Provide prequalification, qualification and validation of supplier programs
  • Develop supplier evaluations/scorecards

Production and Process Controls

  • Ensure production controls consistently deliver products that meet design specifications
  • Develop and implement processes, and help address complaint and failure investigations, nonconformities and CAPA
  • Establish and deliver on key performance indicators and quality metrics


Our staff includes former FDA and EU officials and industry experts who combine global regulatory knowledge with industry best practices to help our clients achieve sustainable and compliant quality systems.

Why Work With NSF?

At NSF, we are committed to protecting patient health and safety. We consistently deliver results through the development and implementation of a comprehensive plan and oversight approach to ensure products are designed and manufactured with quality standards to meet customer and patient needs.

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