White Papers

Planning for Implementation of the European Union Medical Devices Regulations – Are You Prepared?

The Medical Device and In Vitro Medical Device Regulations represent the most significant change to the European legislation for medical devices for nearly 20 years. Understanding the requirements is key to your ability to develop an implementation plan to ensure continuing regulatory compliance and provide the EU market with safe medical devices.

A new white paper, “Planning for Implementation of the European Union Medical Devices Regulations: Are You Prepared?” focuses on the practical aspects of implementation. It discusses decisions that need to be made and includes questions to ask about your organization’s preparedness to comply with the new requirements.

Download this new white paper to learn how to address:

Activities and requirements for manufacturers, authorized representatives, importers, and distributors Existing products and their technical documentation, including clinical evidence Products in the development pipeline Responsibilities of the person handling regulatory compliance, ISO 13485:2016 certification, and lifecycle management Content and maintenance of technical documentation Unique device identification, implant cards, and labelling changes PMS plans, periodic safety update reports (PSURs) or post-market surveillance reports, and post-market clinical follow-up (PMCF)
Posted in: White Papers, Manufacturing & Prototyping, Bio-Medical, FDA Compliance/Regulatory Affairs, Medical
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Epoxy-based Hermetic Feedthroughs Boost Switchgear Reliability

With medium-voltage switchgear, progress is being made with regard to finding alternatives to SF6 as an insulation gas. Designs that incorporate dry air or a mixture of fluoroketone, nitrogen and oxygen as the insulating gas are being explored to minimize environmental impact.

Posted in: White Papers, Aerospace, Defense, Mechanical Components, Mechanics
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Achieving Reliable Inline Measurements in Production Environments

One of the most important changes in metrology in the past few decades has been the development of portable measuring devices. This has brought inspection right to the production line, as close to the part as possible. The change—sparked by the development of portable measuring arms and the emergence of laser trackers—has turned conventional industry inspection methods completely upside down.

Posted in: White Papers, Manufacturing & Prototyping, Software, Test & Measurement
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Design Guide: Sheet Metal Fabrication

Our custom sheet metal services offer a cost-effective, on-demand solution for your manufacturing needs. Fabrication services range from standard gauge metal we can bend, punch and cut your design for low-volume prototypes, to high-volume production runs.

Posted in: White Papers, Manufacturing & Prototyping, Automation
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New GASOMETER Design Uses Active Accommodation Offering Significant Improvements Vs. Liquid-sealed Methods

Active Accommodation means using a precision controlled and driven cylinder/piston assembly to collect and measure gas sample volumes without requiring energy to be extracted from the process that generates the gas. The mechanism uses lubricated O-Rings to seal the measuring chamber unlike classical Wet Test Meters that require a water or oil bath to produce an isolation seal.

Posted in: White Papers, Green Design & Manufacturing, Instrumentation, Test & Measurement
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Optimizing EBM Alloy 718 Material for Aerospace Components

Electronic Beam Melting (EBM) is a leading AM technology that aerospace companies are implementing for production. To leverage the capabilities of EBM, new materials such as Alloy 718 have been developed. Alloy 718 is a nickel-chromium based super alloy ideal for high temperature and corrosive environments, with excellent mechanical properties at elevated temperatures.

Posted in: White Papers, Aerospace, Manufacturing & Prototyping, Materials
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Special Edition: Simulation Gets Personal

To drive sustainable innovation your research and development teams need creative and collaborative ways to think about product, nature, and life working together in harmony.

Posted in: White Papers, Electronics & Computers, Software
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Ensuring the Reliability of Disposable Syringes with Light-Cure Adhesives

Perhaps one of the most challenging aspects of disposable medical syringe production involves permanently and safely attaching the stainless steel cannula to the plastic hub. This joint is critical to the safety of syringes found on hypodermic and biopsy needles, syringes, winged infusion sets, blood lancets, and a variety of other devices. In all these applications, poor hub-to-cannula assembly could result in leakage of bodily fluids and medication or catastrophic device failure, situations that could be dangerous to the patient and the medical professional. Mechanical failure of a syringe can cause painful insertion or extraction, seal failure during use, cancellation of a procedure, or other unsafe complications.

Posted in: White Papers, White Papers, Bio-Medical, Medical
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Antenna Basics

The antenna is the most intrinsic component of all RF systems, yet the principles of antenna design and wave propagation are rarely discussed outside the entry level engineering classes. Rohde & Schwarz has developed an educational white paper on Antenna Basics to reteach the basic principles in a simplified manner.

Posted in: White Papers, White Papers, Aeronautics, Defense, Electronics & Computers, RF & Microwave Electronics
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The Economics of Accuracy in Low-cost, High-volume Sensing Applications

Various research firms forecast the market for portable medical devices to be somewhere around the $20 billion-range within the next several years. Part of the increased demand is due to an aging population with more chronic conditions. These smaller portable units requires devices with smaller footprints. By the same token, smaller devices need to provide adequate levels of care to ensure patient safety and comfort. Thus, functionality cannot be sacrificed for space.

Posted in: White Papers, White Papers, Electronics, Electronics & Computers, Semiconductors & ICs, Data Acquisition, Sensors
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