Newsletter | June 11, 2019

06.11.19 -- Understanding China's Updated Overseas Inspections

 
Featured Editorial
Understanding China’s Updated Overseas Inspections: A Q&A With Gert Bos And Michael Yan
 
By Zachary Brousseau, Regulatory Affairs Professionals Society

China’s National Medical Products Administration (NMPA) has stepped up overseas inspections in recent years, and manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors.

Industry Insights
Selecting The Right Tooling For High-Quality, Cost-Effective Molded Parts
Article | By Craig Brown and Hugh Davies, Caplugs

Using the right combination of tooling and design for injection-molded parts will help ensure high-quality and cost-effective manufacturing.

Evaluating A Multimodal Beam: A Brief Tutorial Highlighting The Use Of BeamGage PRO Partitioning
Application Note | By Mark Szorik, Ophir Photonics

Lasers were initially designed to operate in one fundamental mode. Soon after, researchers devised ways of generating and using more complex, higher-order multimode formats. This application note offers an example tutorial on how to evaluate a multimodal laser beam with BeamGage PRO Partitioning.

New Developments In Parylene Technology For Medical Electronics Advancement
White Paper | By Rakesh Kumar, Specialty Coating Systems

Vapor phase polymers, particularly Parylenes, have become more important in the conformal insulation and biostability of medical electronics and enhancing their overall reliability because of the unique characteristics that are generally not available with other polymeric materials. 

Beyond Making The Part: Understanding Enhanced Qualification
White Paper | By David O’Leary, Eric Landon, and Angela Williams, Accumold

Working with a micro molder to develop an Enhanced Qualification (EQ) process for critical parts can save money and time by ensuring a smooth transition into full-volume production.

Reducing The Life Cycle Cost Of Validation (Part 1): Appropriate Material Selection And Part Design
Article | PTI Engineered Plastics, Inc.

Several key areas with specific criteria are critical to IQ/OQ/PQ processes, yet they are often overlooked or underestimated. In this segment of the series, we will review some of those important details you should consider during material selection and part design.

Living Heart Human Model: Pacemaker Lead Insertion And Cardiac Cycle Simulation Tech Brief
Application Note | Dassault Systemes Americas

The SIMULIA Living Heart Human Model provides a unique testing environment where a pacemaker lead can be virtually inserted and mechanically deformed during the cardiac cycle. Once the mechanical deformation results are obtained, the long-term durability of the implant can be assessed.

Using Thermal Imaging To Detect Small Nerve Fiber Dysfunction
Application Note | FLIR Systems, Inc - Research & Science

While the dysfunction of large nerve fibers can be assessed using standard neurological examination and electromyography (EMG), currently no noninvasive techniques exist to detect and quantify small fiber dysfunction.

Resources
High-Precision Specialty Glass And Lighting Diagnostics
SCHOTT North America, Inc. - Lighting and Imaging
Thermal Imaging Camera With FLIR Cooled InSb Detector: FLIR A6700 MWIR
FLIR Systems, Inc - Research & Science
8.0 mm Ceramic Ball Pressure Relief Valves (For Plastic)
The Lee Company
Inner Rotor Type Brushless Motor: BY54
Canon USA, Inc. Optoelectronic Components
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