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White Papers and Market Updates

Table of Contents for the EU MDR 2017/745

If you have downloaded the 175-page European Medical Device Regulation but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. We have taken the official MDR regulation as published on May 5, 2017 and added a very easy-to-navigate MDR Table of Contents – all in a single PDF.

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How the New EU Medical Device Regulation Will Change Your Approach to CE Compliance

The new Medical Device Regulation (MDR 2017/745) brings a seismic change in how medical devices are regulated in the EU, presenting a whole new set of challenges for RA/QA professionals. In this Market Update we explore seven ways the new EU MDR will affect your approach to CE compliance, and spotlight areas for ensuring sustained compliance.

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Clinical Evaluation Reports 101

Pursuant to MEDDEV 2.7/1 Rev. 4 and the new EU MDR, CERs require more intense literature reviews, more PMS data requirements, more Notified Body scrutiny.  In this Market Update we explore

  • Creating a Solid Clinical Evaluation Plan
  • Literature Search Strategy
  • Clinical Data Analysis
  • Compiling the CER 
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Overview of the European IVDR (2017/746)

Get up-to-speed on the EU IVDR! 

The In-Vitro Diagnostic Regulation (2017/746) will be here before you know it. We explain exactly what you need to know and how to prepare now.

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Table of Contents for the EU IVDR 2017/746

Europe's IVD regulation is 156 pages long...and doesnt have a table of contents! Never fear, we've created one. 

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Medical Device Risk Management 101

Learning the basics of how to analyze, evaluate, control, and monitor risk.

Just getting started with risk management? This White Paper provides a high-level overview of ISO 14971:2019 and an overview of key concepts you should know about before formulating a plan.

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Medical Device Complaint Handling 101

A Primer on the "Who, What, When, and How" of evaluating, reporting, and closing complaints.

In this paper we review the basics of medical device complaint handling, discuss when a medical device incident is reportable, investigating medical device complaints, and take a look at the basics for building a postmarket surveillance (PMS) process. 

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Medical Device Process Validation 101

Understanding Regulatory Requirements, Validation Plans, Writing Protocols, and Executing IQ, OQ, and PQ

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Medical Device Root Cause Analysis 101

Oriel STAT A MATRIX offers guidance on how to define, identify, assess, and diagnose the root cause of problems.

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The FDA 510(k) Process: Improving Your Odds of Success and Shortening Approval Time

A primer on US FDA's registration process for Class II medical devices including how to research and select the right product code and regulation number; how the US FDA uses guidance documents and international standards; the sections of the 510(k), Additional Information requests and more.

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