Newsletter | May 14, 2019

05.14.19 -- Aligning The FDA's QSR With ISO 13485

Featured Editorial
A High-Level Overview Of The Proposed Rule To Align FDA’s QSR With ISO 13485
By Marcelo Trevino, Applied Medical

The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.

Industry Insights
Select The Right Laser Power Sensor By Asking The Right Questions
Article | Ophir Photonics

When a sensor turns out to be an incorrect choice, the system could procure inaccurate measurements, premature failure, and costly full-disc replacement and recalibration. This article presents three critical questions to ask before selecting a laser power sensor for a specific application.

Can The Medical Device Industry Overcome Legacy Sterilization Methods?
Article | REVOX Sterilization Solutions

As companies continue to innovate, they are finding that some of today’s most commonly used sterilization methods impose serious limitations in terms of efficacy, quality, or production processes.

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 is essential to quality in contract manufacturing.

Protecting Inhalation Drug Delivery Devices With Parylene Conformal Coatings
Article | By Dick Molin, Specialty Coating Systems

Inhalers and nebulizers are the most common way to deliver drugs to asthmatic lungs. Recently, many more types of drugs are being delivered with inhalation technologies due to the discovery that these medications readily absorb through the alveolar region directly into blood circulation. 

Taking Micromolding To the Next Level
Article | Accumold

Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with a micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production. 

Evaluating The Increase And Distribution Of Temperature During Dental Drilling Using A Thermal Imaging Camera
Article | FLIR Systems, Inc - Research & Science

In some cases, the rotary speeds from dental drills can cause dangerously high temperatures, which can permanently damage bone tissue as they increase the denaturation of hard tissue proteins. This article discusses research on drilling techniques in a lab setting. 


After another very successful gathering last year, we are proud to announce the Medical Device Manufacturing Summit taking place on June 17 to 18, 2019, at the Cosmopolitan in Las Vegas. At the heart of the event is our unique one-on-one business meetings in which industry services providers are granted access to exclusively C-level, prequalified manufacturing executives within the largest organizations across the U.S. More information.

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