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ISO 9000, Life Sciences, iso 13485

Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both?

Many Life Science organizations are asking that question as new ISO deadlines approach.

Medical device manufacturing companies need regulatory compliance software to maintain compliance and be sure that products are safe and effective. But there are multiple options that complicate the process of deciding which standard to comply with. Some make the decision to comply with more than one for the sake of covering all bases.

Here’s a breakdown of what Life Science organizations should consider about the two most common standards for medical device companies: ISO 9001:2015 and ISO 13485: 2016.

Alexa Sussman
By Alexa Sussman
on Tue, Sep 05, 2017
   
Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both?

Many Life Science organizations are asking that question as new ISO deadlines approach.

Medical device manufacturing...

Alexa Sussman
By Alexa Sussman
on Tue, Sep 05, 2017
Are You Ready for Serialization?

The 2013 Drug Supply Chain Security Act (DSCSA) is aimed at improving end-to-end traceability of pharmaceuticals throughout...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Wed, Jul 26, 2017
What Does the Internet of Things (IoT) Mean for Life Sciences?

The number of networked medical devices is expected to grow 500% over the next decade, putting Internet of Things (IoT)...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Wed, Jul 26, 2017
How to Reduce Recalls with Proactive Risk Management

Risk management starts with identifying key threats. To get a real handle on risks, you must first understand where they...

Emily Ysaguirre
By Emily Ysaguirre
on Tue, May 16, 2017
Does Your Company Make This Common Risk Management Mistake?

There’s a widespread misconception going around about risk management. It’s something you see in the food and beverage...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Tue, Apr 25, 2017
Key Elements of a Quality-Safety Mindset

Imagine watching a lab employee who has just arrived at work. He verifies his training records are up to date, checks for...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Tue, Mar 28, 2017
Software Validation and Change Control: A QMS Compliance Overview

The U.S. Food and Drug Administration (FDA) requires companies to validate any software used in design, manufacture,...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Wed, Mar 15, 2017
Meeting Safety and Quality Goals with a Compliance Management System

Quality and safety, regardless of industry, are not as far off from one another as you’d think. In fact, most organizations...

Emily Ysaguirre
By Emily Ysaguirre
on Wed, Feb 15, 2017
FDA Recommendations for Cybersecurity in Life Sciences

“Cybersecurity threats are real, ever-present, and continuously changing.”

That’s how Suzanne B. Schwartz of the FDA...

Alexa Sussman
By Alexa Sussman
on Tue, Feb 07, 2017

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