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.

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.

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 

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.

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

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.

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.

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. 

In this White Paper we address, WHAT regulations you need to follow; WHERE these regulations apply; WHY you need to follow them, and HOW to get started.

Understanding Regulatory Requirements, Validation Plans, Writing Protocols, and Executing IQ, OQ, and PQ

Oriel STAT A MATRIX offers guidance on how to define, identify, assess, and diagnose the root cause of problems.

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.

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.

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

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).

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 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.

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.

How do you implement Lean to its fullest advantage? How do you know which approach to use and when to use it? How do you address the key drivers of waste?