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White Papers and Market Updates


The New EU Medical Device Regulations: What You Need to Know

New quality system requirements, classification rules, and conformity assessment procedures - these are just a few of the hurdles that manufacturers must clear to sell devices in the EU now that the Medical Device Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR) have been published. This Market Update will help you familiarize yourself with the upcoming changes – and their potential impact on your business.


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.


Medical Device Quality Management Systems 101

An overview of ISO 13485:2016, the US FDA QSR, and Other Important QMS Regulations. If you are new to the medical device industry or simply need to brush up on quality system compliance, you probably have many questions that begin with what, where, why, and how. WHAT regulations do we need to follow? WHERE do these regulations apply? WHY do we need to follow them? HOW do we start?

In this White Paper, we will address all of these questions and many more.


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. 


Understanding the New Requirements of ISO 9001:2015 - Changes and Opportunities for Your Organization

Changes to ISO 9001 create significant ripple effects across many industries, and the 2015 issue is no exception.  This Market Update reviews and explains the major changes in the new standard, the opportunity to use these changes to make your quality management system a strategic driver of performance and sustainability, and the transition period for currently certified organizations.


PRO TIPS: MDSAP Audits

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.


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.


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.


The New ISO 13485: Major Changes Your Organization Must Address

ISO 13485:2016 was published on February 25, 2016.  This market update covers the major changes to the revised standard, and the impact and opportunity presented by these changes.


Do You Work for ISO or Does ISO Work for You?

Did you ever wonder why ISO 9001 certification has not yet had a tangible impact on your company’s overall business performance? Does it feel like you are “working for ISO” as your organization expends a lot of effort and resources in order to avoid trouble with your registrar? If so, consider a holistic approach to managing quality by embracing the guidance given in ISO 9004—have “ISO work for you.”

 
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