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Table of Contents for the EU MDR 2017/745
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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
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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
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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
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Creating a Solid Clinical Evaluation Plan
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Literature Search Strategy
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Clinical Data Analysis
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Compiling the CER
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Overview of the European IVDR (2017/746)
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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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Medical Device Non-Product Software Validation 101
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A step-by-step guide on how to plan, assess risk, write protocols, and conduct tests needed to validate non-product software (NPS) used by medical device manufacturers.
Includes an overview on what non-product software is and why it should be validated; how to create an NPS inventory; how to assess off-the-shelf (OTS) software; and how to create an NPS traceability matrix.
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Medical Device Risk Management 101
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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
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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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Download Pdf
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