Compliance and Remediation Services

Compliance solutions for medical devices

NSF International provides expert compliance solutions to medical device companies. Its staff of former US Food and Drug Administration (FDA) officials, EU officials, and industry experts combines global regulatory knowledge with industry best practices to help you achieve sustainable and compliant quality systems.

NSF’s approach ensures that deficiencies are identified and addressed at their root cause, appropriate procedures and metrics are developed, and linkages between the quality subsystems support continuous improvement resulting in sustainable compliance.

The company provides customised services in the areas of:

Remediation strategy, planning, and execution

  • FDA Form 483 and warning letter responses and correspondence
  • Regulatory agency major nonconformity responses
  • Corrective action planning
  • Import detention and injunction resolution
  • Quality system remediation
  • FDA third-party certification audits

Design

  • Product quality
  • Quality management system (QMS) compliance
  • Compliance auditing and gap assessment

Baseline assessments

  • Due diligence assessments
  • Third-party internal audits
  • Mock regulatory readiness inspections
  • Quality system inspection technique (QSIT) audit
  • Design and development support

Design history file (DHF) development and review

  • Regulatory communications and field actions

Field safety notices (FSN)

  • Field safety corrective actions (FSCA)
  • Recall letters and correspondence
  • Patient and user communications

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