Experienced Medical Device & IVD Specialists Ready to Step In
We typically work with companies who need help in one of these four areas.
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Gap RA/QA Staffing Coverage
If a member of your QA or RA team has recently left your company, we can plug that hole quickly with our team of highly experienced quality and regulatory consultants until a replacement can be hired. Each consultant has demonstrated deep technical knowledge of a wide range of RA and QA disciplines. We can also support the interview process to help ensure that your eventual hire possesses the skills and organizational saavy to be successful in the role on Day 1.
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RA/QA Outsourcing for Startups
Not ready to hire your first QA/RA director? We can step in to help build out your new Quality Management System in compliance with FDA QSR, ISO 13485, MDSAP, or other global requirements. Our regulatory experts can also guide you through early discussions with the FDA, a European Notified Body audit and other global regulatory agencies.
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RA/QA Project Ramp-Up
From reviewing or developing hundreds of Clinical Evaluation Reports (CER), Biological Evaluation Reports (BER), 510(k) or Q-Submissions to overhauling Standard Operating Procedures (SOP), we can jump start a project or add capacity to help meet a looming deadline.
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RA/QA Niche Projects
Have a short-term project to tackle but don’t want to add full-time staff to the payroll? That’s a smart approach when you need specific expertise in a hurry, but you don’t need it forever. We can help.
We Assist Companies with a Variety of Short-Term Needs
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Pre-Market Submissions or Agency Discussions
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Mitigation of FDA Inspection (483) or Notified Body Audit Findings
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Quality Management System Procedure Updates
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European Clinical Evaluation Report Reviews (CER & PER)
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Postmarket Surveillance Program Review & Maintenance
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Q-Submission meetings, IDE, 510(k), DeNovo or PMA Submissions
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Internal, Preassessment, and Supplier Audit Programs
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CAPA Remediation, Complaint Handling, Design Control Process Improvement
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EU MDR & IVDR transition and remediation
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Large Scale Team Training on Various QMS & RA Issues
Our RA/QA Experts
The advantage of working with Oriel STAT A MATRIX is that we have a deep pool of expertise across the US, Europe, Latin America and Asia. Once we fully understand your needs, we will pair you with one or more consultants ideally suited to meet your needs, whether it’s for ten days or ten months! Our consultants...
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Average 25+ years of life sciences industry experience.
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Possess thorough knowledge of the quality, regulatory, and compliance functions throughout the product life cycle in a broad range of product types.
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Have a deep understanding of US, EU and global regulatory and compliance requirements.
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Can determine the significance of quality, regulatory, and/or compliance issues and formulate corrective and preventive action plans to deal with them.
We’re Ready to Step In
Let's discuss your situation and how we might help.