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QMS Compliance

Quality system audits for ISO 13485, US FDA QSR, EU MDR, MDSAP, and more. Move beyond conformance and achieve improved business results! 




Medical device companies must comply with demanding quality standards and regulations, such as ISO 9001, ISO 13485, MDSAP, and FDA’s QSR. Noncompliance with these requirements can impact the effectiveness of your processes, affect the quality of your products, and lead to the loss of certification or even a product recall.

Routine audits are required to ensure ongoing compliance to the requirements. Too often, however, routine audits only address compliance and fail to examine the company’s processes and their interactions. When nonconformances are identified, the audits focus narrowly on a specific correction without considering the systemic impact of the issue or the correction. Over time, organizations can find themselves with compliant yet ineffective quality systems.  

Need an audit done remotely? We can do that.

Move beyond conformance with an Oriel STAT A MATRIX audit

An Oriel STAT A MATRIX quality management system (QMS) audit goes beyond surface findings to examine process interactions and efficiency. Our team of experienced auditors – averaging 25+ years of international and domestic life sciences industry experience – will uncover both compliance gaps and how well your processes (and those of your suppliers) perform. This approach gives your company the information it needs to improve overall performance.

Key Advantage

Oriel STAT A MATRIX is a consulting company, not a certification or regulatory body, so our consultants can provide advice on how to remedy nonconformances.

Access our audit expertise for:

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

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

Get answers right now. Call
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US OfficeWashington DC


EU OfficeCork, Ireland

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+353 21 212 8530

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