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.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

In our July 7, 2017, episode of QDL we look at apprenticeships, the Antikythera mechanism, and risk-based thinking in operations.

“Demand-Driven Education to Close Skills Gap”

Speaking at the National Association of Manufacturers Summit in Washington, D.C., Secretary of Labor Alexander Acosta and House Majority Leader Kevin McCarthy addressed workforce issues.

Amie Whittington’s picture

By: Amie Whittington

Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.

The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (dual status). The circumstances leading up to now are important because the implications can be difficult to understand.

Tim Lozier’s picture

By: Tim Lozier

The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it.

The biggest question often asked is, “I’m aware my company needs to pay great attention to the detail of risk, but I don’t know where to start, or even how to put it into practice.”

Intertek’s picture

By: Intertek

Sponsored Content

As widely useful and broadly applicable as it may be, the ISO 9001 standard covering general requirements for quality management systems (QMS) cannot address all stakeholder needs in every sector. Component functions and operations of discrete industries often require additional standards to ensure that sector-specific procedures are undertaken and completed in a standardized and generally accepted manner.

Intertek’s picture

By: Intertek

Sponsored Content

For organizations within the aerospace sector, certification to the AS9100 family of standards—including AS9110 for aerospace maintenance, repair, and overhaul (MRO) organizations; and AS9120 for aerospace warehouse and distribution operations—is a necessity for doing business. However, it’s also an opportunity to strengthen the inherent quality of the products and services that these companies offer to their customers.

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