Medical Device Compliance and Quality Systems

  • Overview
  • Benefits of Compliance and Quality Services
  • Why Work With NSF?
  • Compliance and Quality Systems Services

NSF International provides third-party, system-based gap analyses as well as targeted assessments of GxP systems. Employing proven methodologies and the extensive expertise of our staff, we assist you with the design and implementation of corrective action plans.

Our experience has helped many companies navigate communications with the FDA and successfully overcome FDA enforcement actions — from FDA 483 inspection findings to warning letters to consent decrees, as well as similar issues with other international regulations like the EU.

We can help your company build and own sustainable, efficient and practical quality systems that meet your business needs and fulfill regulatory requirements, whether as part of an urgent remediation effort or as a preventive measure.

 

Benefits of Compliance and Quality Services

Benefits of using our services incompliance and quality systems include:

  • Our staff consists of industry experts as well as former FDA regulators, assuring alignment with FDA expectations and capitalizing on industry technical know-how.
  • We have developed proven methodologies and a record of success with complex quality and regulatory issues.
  • Our expert advice and guidance assures your company becomes self-sufficient with ownership of the enhanced system.
  • Our detailed knowledge of industry best practices assures practical, doable systems.

Our total product lifecycle approach embodies the concepts of a quality system by establishing links between phases and capturing feedback throughout the lifecycle.

 

Why Work With NSF?

Our experts have regulatory backgrounds or experience in the medical device industry. We are committed to providing the highest quality services based on sound science, risk assessment and common-sense pragmatic solutions to help you achieve your goals. Initial consultations are provided as a professional courtesy.

Compliance and Quality Systems Services

We can provide you with these services in core compliance and quality systems:

  • Third-party GxP system-based gap analyses
  • Targeted assessments
  • Mock FDA audits
  • Mock European regulatory agency audits
  • Corrective action development and implementation
  • Enforcement action remediation and compliance support
    • FDA 483 and warning letter responses
    • Injunction (consent decree)
    • AIP resolution
    • Corporate integrity agreement

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