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Medical Device RA/QA

Medical device regulatory and QMS consulting support spans pre-market, manufacturing and post-market – ensuring you get your medical device and/or IVD to market as quickly and cost effectively as possible, implement an effective and compliant Quality Management System (QMS), and meet compliance and business goals throughout the products life cycle.



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:

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.

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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