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RA/QA Outsourcing

Our highly experienced Medical Device Regulatory and Quality Assurance experts are available to supplement your organization’s efforts, address an immediate regulatory challenge, or provide assistance during periods of organizational transition.

We can help with:

  • Quality Systems support for the various global regulatory compliance requirements and standards, such as ISO 13485, FDA GMP, EU MDR, EU IVDR
  • Support with CAPA, Complaint Handling, Design Controls, and Supplier Quality – or when you require assistance with recalls
  • Mitigating serious Quality System deficiencies, including development and implementation of corrective action plans to address 483 observations, warning letters, or consent decrees.
  • Conduct gap analysis and/or risk assessment and take actions to mitigate risks that have been identified
  • Plan, design, and deliver training programs, including evaluating their effectiveness
  • Audit your Quality Management System or a supplier’s Quality System.
  • Ensure that you are prepared and ready for an FDA inspection or an audit.

Contact us for more information about our Outsourced Services RA/QA support!

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