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

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

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

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

7 QMS Tools to Demonstrate Compliance with 21 CFR Part 820 for Medical Devices

[fa icon="calendar'] Mon, May 07, 2018 / by Rachel Beavins Tracy

21 CFR Part 820 contains a huge number of “shall” requirements for medical device manufacturers. While it may seem impossible to meet so many requirements, a well-constructed Quality Management System (QMS) provides an excellent starting point and framework for compliance.

So how can manufacturers use the QMS to demonstrate compliance with these regulations, and which tools are most important to getting the job done?

Today’s post looks at just that, focusing on 7 specific capabilities to leverage in the QMS.

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Life Sciences

Q&A: What’s the Impact of New EU Medical Device Regulations (MDR)?

[fa icon="calendar'] Fri, Apr 27, 2018 / by Rachel Beavins Tracy

The most sweeping European medical device regulations in decades are slated to go into effect in 2020, leaving many manufacturers wondering what they need to do to get up to speed. Two years may sound like a lot of time to comply, but given the number of changes coming, waiting may not be an option.

We talked to Tony Parise, Life Sciences Product Strategist for EtQ, about what the new requirements mean for medical device manufacturers.

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Life Sciences

Getting Ready for GDPR

[fa icon="calendar'] Mon, Apr 16, 2018 / by Rachel Beavins Tracy

Going into effect May 25, 2018, the General Data Protection Regulation (GDPR) represents the most sweeping changes to EU data privacy laws in 20 years. However, signs are growing that companies are ready for the new requirements, including a new UK report showing fewer than half of organizations have made preparations.

Companies that sell products or services to people in the EU will need to comply with the new regulations or risk a fine of up to 4% of revenue or €20 million, whichever is greater.

In today’s post, we’re examining what companies need to do to get in compliance with the fast-approaching regulatory deadlines.

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Life Sciences General Quality

What Are the Changes in ISO 13485:2016?

[fa icon="calendar'] Fri, Apr 06, 2018 / by Rachel Beavins Tracy

If your organization is one of the more than 59,000 certified to ISO 13485, you should already be planning for your transition to the newest version of the standard. As of February 28, 2019, all ISO 13485:2003 certificates will expire, with the Medical Device Single Audit Program (MDSAP) requiring manufacturers to transition by January 1, 2019.

ISO 13485 is based on the popular ISO 9001 for quality management systems, although key structural differences make it a standalone standard. In this post, we’re looking at what the changes are in ISO 13485:2016, and what companies can do to streamline the transition process.

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Life Sciences

3 Things You Need to Know About the MDSAP

[fa icon="calendar'] Mon, Mar 26, 2018 / by Alexa Sussman

Audits are an essential part of the Life Sciences as they ensure manufacturers are producing safe products and operating within compliance.

Previously, audits meant surprise business interruptions for manufacturers and a lot of travel and administrative work for auditors. With many Life Science manufacturers operating internationally, they were being audited separately to satisfy the requirements of each country in which they operated. At the end of the day, there was a lot of repeat work on both ends.

So regulatory agencies and legislators have come together to develop single audit programs that create comprehensive audits that satisfy the requirements of multiple countries. This creates a globally harmonized and efficient international audit management system.

One of the major programs is the Medical Device Single Audit Program (MDSAP). As the deadlines for these changes approaches quickly, here are 3 things that medical device manufacturers should know about the MDSAP.

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Life Sciences General Quality

4 Ways to Manage Post Market Events in Life Sciences

[fa icon="calendar'] Fri, Mar 09, 2018 / by Alexa Sussman

You have a solid quality system in place for product design, production and testing. Your medical devices pass all tests with flying colors. You’re off the hook once they leave for distribution, right?

Wrong.

Quality management extends beyond your four walls. If a product has your name associated with it, it’s your responsibility even once it’s in the hands of patients.

Here are four ways to effectively manage postmarket events with automated Quality Management System (QMS) software.

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Life Sciences