Ryan E. Day’s picture

By: Ryan E. Day

What do cocoa, socks, and smartphones have in common? If you guessed risk of slavery in the manufacturing supply chain, you are correct. Does your organization have an international supply chain? Then it’s at risk. What are you doing to address the risks associated with modern slavery in your supply chain?

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.

“Climbing Stairs Just Got Easier With Energy-Recycling Steps”

These stairs actually help you go up.

Sal Lucido’s picture

By: Sal Lucido

Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated process management system lies the unsung yet essential electronic form. You can avoid quality management system (QMS) form design mistakes by following some proven guidelines.

Forms are the arteries that pump information to the heart of your QMS. They do this in the following ways:

Mike Richman’s picture

By: Mike Richman

The dog days of summer are here, but the Aug. 4, 2017, episode of QDL offered lots of cool content. Let’s take a closer look:

DNV GL’s picture


Bribery and corruption are a $1 trillion drain on the global economy and a door-shutting event for companies unable to prevent rogue acts from destroying a company’s entire reputation. If you think about it, managing bribery is a bit of an oxymoron. How do you manage something that hasn’t happened and you hope will never happen?

AssurX’s picture

By: AssurX

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.

Elizabeth Gasiorowski Denis’s picture

By: Elizabeth Gasiorowski Denis

Scott Gottlieb’s picture

By: Scott Gottlieb

It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, the FDA can promote health through the creation of more new and beneficial medical technologies.

Pam Bethune’s picture

By: Pam Bethune

Every company is in business to take risks.

Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to identify opportunities and take them when beneficial, but the amount of risk must be understood. Whether it’s determining to pursue new markets and make new investments or discontinuing those pursuits, risk is built into the nature of business.

Claire McCluskie’s picture

By: Claire McCluskie

With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some uncertainty about the effect that one of the standard’s key changes might have on their business: computer software validation.

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