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Life Sciences

What Does EU’s New MDR Mean for Small to Medium-Sized Companies?

As of 2020, medical device companies that market products in Europe will be subject to a much larger set of requirements that mirror rigorous U.S. Food and Drug Administration (FDA) regulations.

And while large companies have extensive resources to pour into complying with the new EU Medical Device Regulation (MDR), it’s not necessarily true for smaller companies. In fact, some experts predict that the new requirements could wipe out some organizations altogether.

In today’s post, we’re looking at what small to medium-sized medical device companies need to know about the new EU MDR. We’ll examine some of the most important changes, timing considerations and practical steps to take now to successfully manage the transition.

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, Jun 18, 2018
   
What Does EU’s New MDR Mean for Small to Medium-Sized Companies?

As of 2020, medical device companies that market products in Europe will be subject to a much larger set of requirements...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, Jun 18, 2018
The Industrial Internet of Things (IIoT) for EHS: Risks and Rewards

TechTarget defines an Internet of Things device as “any nonstandard computing device that connects wirelessly to a network...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Jun 15, 2018
Documentation Requirements in ISO 13485 - Start with a Quality Management System (QMS)

When it comes to ISO certifications, one thing companies can count on is a mountain of documentation.

It’s especially true...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Jun 08, 2018
Using the Quality Management System (QMS) to Support the 8 Principles of Total Quality Management (TQM)

Total Quality Management (TQM) emerged in the 1980s in response to economic losses experienced due to Japanese manufacturers...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Jun 01, 2018
MDR and IVDR - What Medical Device Manufacturers Need to Know About New EU Standards

Big changes are on the horizon for medical device manufacturers who market and sell their devices in Europe. On May 5, 2017...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, May 28, 2018
How the Internet of Things Can Transform Manufacturing Safety

More than 1 in 3 U.S. manufacturers are using smart sensors to collect and analyze data to improve their processes. The...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, May 25, 2018
5 Tips for Automating Your Good Manufacturing Practice (GMP) Compliance Management Processes

More and more life science companies are moving towards an automated GMP compliance management system, with the goal of...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, May 18, 2018
How Machine Learning Can Transform Quality Management

Services like Netflix, Google and Facebook are known for using predictive technology to learn our preferences and provide...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, May 11, 2018
7 QMS Tools to Demonstrate Compliance with 21 CFR Part 820 for Medical Devices

 

How a Quality Management System Can Ensure Compliance With FDA 21 CFR Part 820

21 CFR Part 820 contains a huge number of...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, May 07, 2018

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