What Are the Changes in ISO 13485:2016?

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

Transitioning to the New 13485:2016 Standard - Ensuring Compliance

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 to the latest standard 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

4 Best Practices for Leading Metrics

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

The ECA Academy shared that in 2016, most GMP inspection deficiencies involved quality systems—more specifically, the Corrective and Preventive Action (CAPA) process.

A closer look revealed that root cause analysis and impact assessment are still a challenge for many organizations. These organizations struggle with taking measures to prevent recurrence of adverse events.

A possible explanation for this challenge is that organizations are not leveraging leading and lagging indicators to their advantage when building corrective action management processes.

Learning to understand leading and lagging metrics and how to use them in your organization can be a gamechanger in the Life Sciences.

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Life Sciences

Avoid FDA Warning Letters with These 4 Document Control Best Practices

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

Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures. Employees shredding documents without bothering to record why and what they were destroying, even as inspectors were onsite.

These practices may sound outrageous, but the document control horror stories are all right there in the U.S. Food and Drug Administration (FDA) warning letters. Even organizations that wouldn’t dream of engaging in such obvious violations could be subject to 483 notices and warning letters if they don’t get document control right.

With that in mind, let’s take a look at 4 document control best practices to help companies avoid FDA warning letters.

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Life Sciences

How a Good Corrective Action Plan Helps You Comply with ISO 13485:2016

[fa icon="calendar'] Fri, Jan 26, 2018 / by Alexa Sussman

quality_icons.jpgISO 13485:2016, A Review

ISO 13485:2016 is the latest revision of the standards for quality management systems in medical device manufacturers and their suppliers.

Since companies only have until September 2018 to comply with these standards, it’s important to understand the main takeaways of the latest revision:

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Life Sciences

Understanding the Basics of ISO 13485 for Medical Device Quality Management Systems (QMS)

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

ISO 13485 for Medical Device Quality Management Systems is growing in popularity, with the number of certified facilities jumping 13% from 2015 to 2016.

But how is ISO 13485 different from ISO 9001 for Quality Management, and who should certify?

In this post, we’ll take a look at the basics of ISO 13485 to help you decide whether it’s worth pursuing this certification.

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Life Sciences

4 Risk Management Gaps and Opportunities [Infographic]

[fa icon="calendar'] Thu, Dec 07, 2017 / by Rachel Beavins Tracy

To achieve operational excellence, you need a comprehensive, forward-thinking approach to managing safety and quality risks.

This infographic identifies 4 of the most common risk management gaps and shows you how solutions like quality management software can help mitigate these risks.

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Risk Management Quality Management Food and Beverage Life Sciences EHS

6 FDA-Recommended Considerations for Smart and Safe Medical Device Interactions

[fa icon="calendar'] Wed, Nov 29, 2017 / by Alexa Sussman

In September 2017, the FDA announced a guidance called “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance will help Life Science organizations via considerations for design and development of medical devices to safely exchange information.

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Life Sciences

Tips for Managing the Top 5 Life Sciences Risks [Infographic]

[fa icon="calendar'] Tue, Nov 07, 2017 / by Rachel Beavins Tracy

Life sciences companies face risks that threaten product quality, patient safety and profitability--this infographic reviews these risks and provides tips for mitigating them. Read More

Life Sciences Risk Management