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

[fa icon="calendar'] Mon, Jun 18, 2018 / by Rachel Beavins Tracy

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.

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Life Sciences

The Industrial Internet of Things (IIoT) for EHS: Risks and Rewards

[fa icon="calendar'] Fri, Jun 15, 2018 / by Rachel Beavins Tracy

TechTarget defines an Internet of Things device as “any nonstandard computing device that connects wirelessly to a network and has the ability to transmit data.”

The Industrial Internet of things (IIoT) has the potential to revolutionize manufacturing, not least of all when it comes to health and safety. What’s equally clear is that implementing IIoT is a huge undertaking, and not without its risks.

In today’s post, we’ll look at what environmental, health and safety (EHS) professionals can expect with the evolution towards IIoT, both in terms of risks and benefits.

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EHS

Examining the Documentation Requirements in ISO 13485

[fa icon="calendar'] Fri, Jun 08, 2018 / by Rachel Beavins Tracy

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

It’s especially true for certifying to ISO 13485 for medical device quality management, as medical device manufacturers must provide extensive documentation as evidence of the safety of their products—and the effectiveness of their quality processes.

In today’s post, we’re examining ISO 13485:2016 documentation requirements to help manufacturers get organized as they transition to the latest standard version.

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Life Sciences

3 Ways Blockchain is Transforming Manufacturing

[fa icon="calendar'] Mon, Jun 04, 2018 / by Alexa Sussman

Traditional business methods are enough to handle basic manufacturing processes but can’t keep up with the pace at which markets and technology are advancing.

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General Quality

Using the QMS to Support the 8 Principles of Total Quality Management

[fa icon="calendar'] Fri, Jun 01, 2018 / by Rachel Beavins Tracy

Total Quality Management (TQM) emerged in the 1980s in response to economic losses experienced due to Japanese manufacturers producing higher quality goods at lower cost. TQM was a natural outgrowth of the Toyota Production System, eventually giving rise to approaches like Lean Manufacturing and Six Sigma.

Companies that adopt TQM and related process excellence methodologies need a specific set of Quality Management System (QMS) tools. With that in mind, today we’re looking at how the QMS supports what the American Society for Quality (ASQ) calls the 8 principles of TQM.

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General Quality

What Medical Device Companies Need to Know About New EU Standards

[fa icon="calendar'] Mon, May 28, 2018 / by Rachel Beavins Tracy

Big changes are on the horizon for medical device manufacturers who market and sell their devices in Europe. On May 5, 2017 the European Union (EU) published updated regulations on medical device safety and quality, including the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

These new regulations represent the first major update to EU medical device standards in more than two decades. What’s more, they’re set to replace all three existing Medical Device Directives (MDD).

So what will the new standards mean for medical device manufacturers? This post looks at some key considerations in terms of timing, quality management practices and clinical requirements.

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Life Sciences

How the Internet of Things Can Transform Manufacturing Safety

[fa icon="calendar'] Fri, May 25, 2018 / by Rachel Beavins Tracy

More than 1 in 3 U.S. manufacturers are using smart sensors to collect and analyze data to improve their processes. The Internet of Things (IoT), which simply means connecting non-computing devices via the Internet, is rapidly evolving and shaping how companies do business.

One of the most meaningful impacts IoT technology can have is in the realm of safety, helping reduce the 2.9 million workplace injuries and illnesses that occur every year.

With that in mind, let’s look at how companies are using IoT to address workplace safety, including areas like equipment safety, personal protective equipment (PPE) and emergency response.

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Quality Management EHS

Why Innovation is Key to Food Waste Reduction in the Supply Chain

[fa icon="calendar'] Wed, May 23, 2018 / by Tim Lozier

Pressure to reduce food industry waste is transforming the way companies operate. Here, we take a look at how innovative technology and integrated management systems can support ambitious goals.

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5 Most Useful Resources for Starting Out in Quality

[fa icon="calendar'] Mon, May 21, 2018 / by Alexa Sussman

If you’re just getting started as a quality professional, it can be overwhelming. If you’re unfamiliar with the industry, it’s hard to even know where to find guidance.

To help you get started, we’ve put together some of the best quality and compliance resources we know.

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Quality Management

5 Tips for Automating Your GMP Compliance Management Processes

[fa icon="calendar'] Fri, May 18, 2018 / by Rachel Beavins Tracy

More and more life science companies are moving towards automated GMP compliance management, with the goal of streamlining processes to make them leaner and more efficient.

For example, we’ve found that companies who implement automated Quality Management Software to manage adverse events saves time equivalent to 3 full-time employees. Rather than chasing down administrative details, these people can instead focus on value-added activities where their efforts have a bigger impact.

What do organizations need to know to get the most from automation? Today’s post looks at key strategies like customizing workflows, integrating applications and getting more from your reporting.

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Life Sciences