White Papers and Market Updates

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.

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.

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

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. 

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.

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).

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.

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.

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.

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.