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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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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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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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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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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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Medical Device Single Audit Program (MDSAP) FAQs

MDSAP is well under way, and with its rollout come many questions. 

At Oriel STAT A MATRIX we get many questions about MDSAP, so we've compiled the most common ones - and our responses - in this handy FAQ. Get Answers to FAQs like: Who needs to comply, how much does it cost, how to prepare, aftger the audit and more.

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Medical Device Design Control 101

A primer on how to properly document your design and development process, track subsequent changes, and understand what’s required by law. 

Includes an overview of what, why, and how of design controls; the meaning of design inputs, outputs, verification, and validation; and the difference between a Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR).

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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) 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 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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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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