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White Papers and Market Updates

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

The new Medical Device Regulation (MDR 2017/745) represents a seismic change in how medical devices are regulated in the EU. Complying with the new regulation presents a whole new set of challenges for RA/QA professionals. In this Market Update we explore 7 ways the new EU MDR will change your approach to CE compliance and explore areas to consider so as to ensure sustained compliance.

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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 and an overview of key concepts you should know about before formulating a plan.

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Medical Device Supplier Quality Management 101

Learn the basics of maintaining quality control of your purchased products while meeting US FDA, EU MDR, and ISO 13485 requirements.

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The process to get certified to MDSAP is different from a standard ISO or QSIT audit and will require some changes in how QA and RA think about audit preparation. Here are some useful tips the Oriel STAT A MATRIX team has picked up from helping our customers successfully prepare for and pass their MDSAP audits.

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Becoming an Effective ISO 13485:2016 Auditor 101

Planning and Conducting QMS Audits that Yield Useful Results (and Add Value to the Business). 

If you will be participating in (or leading) an internal ISO 13485 audit for the first time, you likely have many questions. Oriel STAT A MATRIX has answers. This White Paper explains the basics of what you need to know before conducting your first medical device QMS audit.

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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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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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PRO TIPS: Complaint Handling

While many medical device manufacturers view complaint handling as solely a regulatory compliance requirement, leading companies embrace it for the trove of data it provides. A well-designed system of intake is one of the most valuable ways to monitor feedback, allowing you to share important product information with your R&D, manufacturing, sales, marketing, and technical support teams. Follow these pro-tips to maximize your complaint handling process.

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Medical Device Quality Management Systems 101

An overview of ISO 13485:2016, the US FDA QSR, and Other Important QMS Regulations. 

New to the medical device industry or simply need to brush up on QMS compliance? You probably have many questions that begin with what, where, why, and how. WHAT regulations do we need to follow? WHERE do they apply? WHY do we need to follow them? HOW do we start? In this White Paper we address these questions and more.

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Increasing the Value of Audit Programs with Performance Based Auditing

Think back to your last round of internal audits…Can your organization use the audit findings to improve overall performance and efficiency? For too many organizations, the answer is "no." Their audit programs focus on conformance and miss opportunities to improve organizational performance. In this White Paper, we explore four ways to increase the value of your audit program.

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