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The QMSR is Coming: Preparing for the FDA's Shift to ISO 13485

The clock is ticking! With the FDA's new Quality Management System Regulation (QMSR) less than a year away, are you ready for the shift to ISO 13485:2016? Our blog provides essential insights and guidance for a smooth transition.

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Beyond MDR/IVDR: Preparing for the EU AI Act in Medical Devices

Is your medical device integrating AI? The EU's new AI Act is here. Learn how to navigate its requirements alongside the MDR/IVDR and ensure seamless market access with our expert analysis and guidance.

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Extended Relief, Not Relaxation: Mastering the EU IVDR Transition Periods

The extended IVDR transition periods offer more time, but compliance remains crucial. Our blog outlines the updated deadlines and essential steps for manufacturers to meet the stringent requirements of the EU IVDR.

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NEW! DaySmart Training Classes.
One Day and Done — Only $995!

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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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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Blog

LDT testtubes
Oct 04, 2023

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

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blog lasar facial
Sep 19, 2023

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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