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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.

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Consulting

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

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US OfficeWashington DC

1.800.472.6477

EU OfficeCork, Ireland

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+353 21 212 8530

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