Medical Device RA/QA Consulting
From pre-market through a products commercialization, our regulatory affairs and quality assurance experts collaborate with Device and IVD manufactures across the globe to:
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Design a regulatory strategy for obtaining approvals or clearances to commercialize medical device and/or IVD in the US, EU, Canada, Australia, Japan, and other markets
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Determine the medical device classification
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Identify and recommend potential regulatory pathways, including those for borderline products
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Plan and prepare pre-submission (e.g., Q-submission, 513(g) product classification, and pathway) discussions with the regulatory agencies
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Plan and compile documentation for regulatory submissions, including:
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Determine relevant quality system requirements based on the complexity of the device and the level of risk
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Implement a new QMS or improve your existing processes
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Provide for Connected Medical Devices, SaMD & IoMT regulations, standards, and guidance
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Conduct Internal and Supplier audits for FDA, EU MDR / IVDR, MDSAP and ISO 13485
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Develop harmonized quality systems that provide efficiency and will withstand regulatory scrutiny.
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Develop global strategies for UDI implementation.
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Respond to enforcement actions.
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Plan and implement effective responses and corrective actions to warning letters, Form 483s, consent decrees, and other findings.
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Provide training on foundation through advanced regulatory topics including topics like ISO 13485 and QSR Basics to EU MDR Auditing and more.
Why choose Oriel STAT A MATRIX?
In 1977, FDA chose Oriel STAT A MATRIX to work with the agency to train their investigators in the new draft Good Manufacturing Practice (GMP) regulations, the precursor to the current cGMP/Quality System Regulation (QSR). Since then, we’ve developed the experience needed to support medical device manufacturers at every step – from achieving compliance with FDA and global regulations to making processes more effective and efficient to improve business results.