Newsletter | February 9, 2021

02.09.21 -- Closing The Loop On Risk Management With ISO 14971:2019
 
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Featured Editorial
Closing The Loop On Risk Management With ISO 14971:2019
 
By Edwin L. Bills, member, ISO TC 210 JWG1

Edwin L. Bills, member of ISO TC 210 JWG1, discusses the evolution of risk management standards for medical devices and how ISO 14971:2019's revision (which is also identical to EN ISO 14971:2019) is meant to "close the loop." Based on the extensive changes in Clause 10, all manufacturers of medical devices and in vitro medical devices will need extensive review and possible changes to their production and post-production activities section of their quality systems in order to meet the new requirements.
Industry Insights
Why Extruded Tubes May Be Your Best Medical Device Packaging Option
Article | By Mike McElhaney, Caplugs

Protecting your valuable medical products is of the utmost importance, but it often comes with a hefty price tag and unforeseen challenges. Rigid extruded tubes (ExT) can offer an affordable, customizable, durable, reusable, and sterilizable packaging option for your medical product.
Container Closure Integrity Testing: The Importance Of Sensitivity, Automation, And Efficiency
White Paper | By Oliver Stauffer and Michelle Wolf, PTI Packaging and Inspection Systems

This article explores the need for sensitive, reliable, and automated container closure integrity (CCI) testing technologies and how existing deterministic solutions can help achieve optimum quality assurance goals in CCI for pharmaceutical manufacturers.
Keys To Driving Consistent Quality In Contract Manufacturing
Article | SMC Ltd.

Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.
When Reliability Is Paramount: Selecting Capacitors For Life-Critical Applications
White Paper | Knowles Precision Devices DLI

This white paper explores regulation, testing procedures, and supplier considerations to assist in choosing the best components for each medical application. 
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