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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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25 EU MDR Requirements That Apply to Legacy MDD Devices in 2023

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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Stay ahead of fast-moving medical device regulatory changes.

Choose from dozens of classes – offered virtually or in-person – each taught by experienced instructors in an unmatched hands-on format that’s been fine-tuned over 50 years

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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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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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The Oriel STAT A MATRIX View

Access timely insights on performance excellence and RA/QA topics from Oriel STAT A MATRIX thought leaders.

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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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Company Update

The Validant Group – the parent company of Oriel STAT A MATRIX - has announced Tim Dietlin as new CEO.

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Medical Device
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Blog

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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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Aug 07, 2023

How Indications for Use Impact Medical Device Classification

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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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HOW CAN WE HELP YOU?

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