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

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

 

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

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 to assist with 21 CFR Part 820 compliance.

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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