How To Map Your QMS To EU MDR Requirements

[fa icon="calendar'] Fri, May 31, 2019 / by Rachel Beavins Tracy

 

Medical device manufacturers who are not up to speed with the latest European Union compliance requirements could find themselves struggling to catch up.

In May 2017, the EU adopted some of the most sweeping changes to medical device regulations in more than two decades. With the system long considered to be in need of modernization, the new rules under the EU Medical Device Regulation (EU MDR) framework have been drafted with patient safety in mind.

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Quality Management Medical Devices Life Sciences Europe Regulatory Compliance SaaS

Webinar: How To Prepare For FDA Migration To ISO 13485 And MDSAP

[fa icon="calendar'] Mon, May 06, 2019 / by David Bolton

 

Media theorist Marshall McLuhan may not have had quality management for medical devices in mind when he coined the phrase “global village” in the 1960’s, but the fundamental interconnectedness of modern society has brought his concept to life. And while technology is at its core, the need for international harmony in the regulatory sphere is arguably a key QMS issue.

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Medical Devices ISO Standards Life Sciences Regulatory Compliance iso 13485

ETQ Reliance 2019 Now Available

[fa icon="calendar'] Tue, Jan 29, 2019 / by Morgan Palmer

We are excited to announce the release of ETQ Reliance 2019, a major upgrade to our flagship QMS SaaS product. The latest release of ETQ Reliance includes an entirely new User Interface (UI) and updates that improve personalization and collaboration.

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quality management software Medical Devices Food Safety Management System Life Sciences Aviation Safety Management Food and Beverage Safety quality Document Control Nonconformance Employee Training Software Supplier Quality Management Innovation Product Updates quality system Company News SaaS

4 Things Life Sciences Companies Should Know About FDA Warning Letters

[fa icon="calendar'] Fri, Aug 17, 2018 / by Rachel Beavins Tracy

The number of warning letters handed out by the U.S. Food and Drug Administration (FDA) has been on a steady rise over the past several years. In fact, the agency handed out more than 100 warning letters in 2016 alone, often after missed opportunities to correct mistakes pointed out in Form 483 observation reports.

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Life Sciences

ISO 13485 Countdown: 5 Critical Tasks to Focus on Now

[fa icon="calendar'] Thu, Jul 12, 2018 / by Rachel Beavins Tracy

The clock is ticking: in less than a year—February 28, 2019—previous ISO 13485:2003 certificates will no longer be valid. And if you plan to participate in the Medical Device Single Audit Program (MDSAP), that deadline is even earlier, as you’ll need to make the switch by the first of the year.

If you feel like you’re behind schedule, taking concrete action can help eliminate some of the stress. Let’s look at 5 practical steps you can focus on right now to make sure you’re ready ahead of the deadline.

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Life Sciences

3 Steps to Achieving Manufacturing Operational Excellence

[fa icon="calendar'] Thu, Jul 05, 2018 / by Alexa Sussman

Gartner’s five stage manufacturing maturity model helps organizations improve their manufacturing processes and supply chain management.

This is especially important as organizations need a holistic strategy to build their existing capabilities to adjust to new initiatives such as Industry 4.0 and factory of the future.

Adopting Gartner’s five stage manufacturing maturity model helps organizations advance in three main ways: identifying current maturity levels an identify which dimensions are lagging, making a plan that leverages current practices to prioritize necessary changes and engaging stakeholders while road-mapping programs to incrementally mature operations.

Here’s more on each.

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Life Sciences

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

Documentation Requirements in ISO 13485 - Start with a Quality Management System (QMS)

[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

MDR and IVDR - What Medical Device Manufacturers 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 Good Manufacturing Practice (GMP) Compliance Management Processes

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

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

For example, we’ve found that companies who implement an automated Quality Management Software solution 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 processes and workflows, integrating applications and getting more from your reporting.

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Life Sciences

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