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Staff Augmentation/ Outsourced RA/QA Support

Oriel STAT A MATRIX’s staff augmentation and outsourced RA/QA support program is designed to address fluctuating resource capability or capacity so you can manage and sustain US FDA, EU, and international regulatory requirements.

How We Help

Deployed in a flexible and cost-effective approach, 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.

Our medical device and IVD regulatory and QMS compliance experts can help when you need to:

  • Facilitate global regulatory compliance to applicable requirements and standards, such as ISO 13485, FDA GMP, EU MDR, EU IVDR, and other quality system specifications.
  • Prepare a global regulatory strategy, 510(k) or PMA submission, STED application, design dossier/technical file, and other product registration documentation for regulatory submission and worldwide product registration.
  • Develop / update Clinical Evaluation Reports (CERs), Technical Documentation, Performance Evaluation Reports (PERs) for EU MDR / IVDR compliance.
  • Obtain independent expert quality and/or regulatory guidance on project teams in commonly known problem areas within a Quality System, such as CAPA, Complaint Handling, Design Controls, and Supplier Quality – or when you require assistance with recalls.
  • Mitigate serious Quality System deficiencies, including development and implementation of corrective action plans to address 483 observations, warning letters, or consent decrees.
  • Establish and maintain relationships with regulatory agencies, including US, international, and selected registrars, or Notified Bodies.
  • 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.

Our FDA / EU MDR experts:

  • Have an average of 25+ years of life sciences industry experience.
  • Possess thorough knowledge of the quality, regulatory, and compliance functions throughout the product life cycle in a broad range of product types.
  • Are familiar with both U.S. and global regulatory and compliance requirements.
  • Have extensive experience in the field.
  • Can determine the significance of quality, regulatory, and/or compliance issues and formulate corrective and preventive action plans to deal with them.

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

Oriel STAT A MATRIX has been focused on Medical Device RA/QA for 50+ years. We have trained and advised regulatory professionals at thousands of companies. Give us a call or contact us online to start a discussion about how we may assist you.

Provided below are a variety of practice related white papers, market updates and case studies.

Bolster Your In-House Resources with Staff Augmentation from Oriel STAT A MATRIX

Get answers right now. Call 1.800.472.6477