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.