Quality Systems and Compliance

Overview

NSF International provides expert compliance solutions to medical devices companies. Our staff of former FDA and EU officials and industry experts combines global regulatory knowledge with industry best practices to help you achieve sustainable and compliant quality systems. Our systems approach ensures that deficiencies are identified and addressed at their root cause, appropriate procedures and metrics are developed and that linkages between the quality subsystems support continuous improvement resulting in sustainable compliance.

For more information about NSF medical device quality systems implementation, remediation and auditing, please email chinalab@nsf.org  or call +86 21 52377700.

 
Services

Our comprehensive 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
 
Experts

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.

  1. Tom Dzierozynski, Executive Vice President, NSF Avarent
 
Success Stories

Challenge: A Fortune 500 medical device manufacturer needed support following an FDA warning letter.

Solution: NSF provided strategic support and hands-on consultation for a remediation effort covering the seven subsystems of the QSR. As part of this multi-phased approach, NSF led training and coaching sessions for company subject matter experts, developed the remediation program including the creation of a program charter, and built and managed the Program Management Office.

Challenge: A Fortune 500 Class II medical device manufacturer wanted to remove a consent decree.

Solution: NSF conducted a series of baseline and verification audits, and provided ongoing support following these audits at the facilities and for the products identified in the consent decree. We also served as the third-party certifier for three separate quality systems certifications as identified in the consent decree.

Challenge: A global medical device manufacturer was facing withdrawal of CE certification for its Class IIb and III products.

Solution: NSF mobilized a team of senior EU regulatory specialists to work in various locations in both the U.S. and UK. NSF acted as intermediaries between several EU competent authorities and the notified body to establish an appropriate action plan to address fundamental regulatory, product validation and quality system deficiencies. NSF coordinated and managed the implementation of regulatory and clinical processes to remediate multiple technical files leading to the successful reissue of CE certification.

 

 
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.