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NEW! DaySmart Training Classes.
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Need to get up-to-speed quickly but don’t have the time, need, or budget for an intensive multiday class? DaySmart classes are for you.

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EU Medical Device Regulation Compliance Making Your Head Spin?

You’re not alone: the MDR is way more complex than the MDD it replaces. Find out where you stand in terms of MDR compliance with an EU MDD to MDR gap analysis. Learn how.

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Short Staffed?
Experiencing Project Overload?

Whether you’re a start-up that needs short-term RA/QA expertise, or an established company with more projects than staff to handle them, we can help. Learn how.

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25 EU MDR Requirements That Apply to Legacy MDD Devices Right NOW

Think you have years to comply with the EU MDR? Think again. Your Notified Body expects you to be fully compliant with these MDR requirements NOW.

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Are You Prepared For Your Next FDA Inspection or Notified Body Audit?

Eliminate surprises. Let our team of specialist medical device QMS auditors determine whether you meet the requirements of 21 CFR Part 820, ISO 13485 and/or MDSAP.

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Medical Device Clinical Evaluation Reports Giving You Heartburn?

Notified Bodies expect to see robust clinical data in accordance with MEDDEV 2.7/1 Rev 4 but many companies struggle to meet strict CER requirements. We can help.

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Implementing the New EU In Vitro Diagnostic Regulation (IVDR)

The IVDR is far more comprehensive than the IVDD it replaced. Let us help you follow the new requirements.

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FDA to Regulate Lab Developed Tests (LDTs) as Early as 2025

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Regulatory Requirements for EU MDR Annex XVI Devices: What You Need to Know

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Aug 21, 2023

How to Transition Your Medical Device EUA to an FDA 510(k)

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GET TO KNOW US...

Since 1968, Oriel STAT A MATRIX has helped medical device and diagnostic manufacturers improve performance, achieve regulatory compliance, and secure sustainable success. Life sciences companies rely on our subject matter expertise, experience supporting industry leaders, and ability to deliver results that matter.

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Oriel STAT A MATRIX’s Goal

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

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