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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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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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The Simple Guide to a Life Science Recall

Recalls erode consumer trust, brand integrity, company image and longevity. Since there is a lengthy process that follows the event of a recall, here is how a GMP Compliance Management System can help to make the process as efficient, painless and quick as possible.Download this paper to learn about: Complaint Handling Product Returns Document Control Recall Evaluation Corrective Action Centralized Reporting

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

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Laser Treatment Supports New Paper Electronics

By using lasers to treat graphene, Iowa State University researchers have found new ways to enable flexible, wearable, and low-cost electronics. Fabricating inkjet-printed, multi-layer graphene electric circuits and electrodes with a pulsed-laser process improves electrical conductivity without damaging paper, polymers, or other fragile printing surfaces.

Posted in: News, News, Diagnostics

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A Simplified Production of Organic Compounds Containing High Enantiomer Excesses

NASA has developed a novel approach for producing sugars and sugar acids enriched with one of the two enantiomers of individual compounds. This approach can also be adapted for other compounds, such as amino acids. All objects, including chemical compounds, have mirror images, some of which cannot be superimposed. In the case of chemical compounds, these non-superimposable mirror images are called enantiomers and are widely used in biological processes. NASA’s method produces high enantiomer excesses from simple and relatively inexpensive precursors (formaldehyde and simple salts) and hardware components without the need and expense of using (at some stage) biological sources. Unlike the commercial production of most rare enantiomers, this innovation employs conditions that are extremely common, non-biological, and relatively inexpensive to set up.

Posted in: Briefs, Medical, Catalysts, Production, Chemicals

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Generation of High-Pressure Oxygen Via Electrochemical Pumping in a Multi-Stage Electrolysis Stack

Innovators at NASA’s Glenn Research Center have developed a method for producing pure high-pressure oxygen via an electrochemical pumping process through a solid oxide electrolysis (SOE) cell stack. Glenn’s device can either concentrate the oxygen in the ambient atmosphere or extract the oxygen via the chemical reduction of carbon dioxide, water, or any combination of these substances. This solid-state device does not use any moving parts or any extra separation processes to purify the delivered oxygen. Instead, Glenn’s technology relies on a multi-stage stack design and an SOE process that includes an oxygen-ion-conducting ceramic membrane to generate high-pressure oxygen within a compact, noiseless device. This process has great potential for use in medical, industrial, and recreational applications.

Posted in: Briefs, Medical, Life support systems, Oxygen equipment

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Tension Distribution in Tendon-Driven Fingers

The technology can be used in telemedicine, surgical robotics, home medical service robotics, medical rehabilitation, and hospital service robotics. Researchers at the NASA Johnson Space Center (JSC), in collaboration with General Motors and Oceaneering, have designed a state-of-the-art, highly dexterous, humanoid robot called Robonaut 2 (R2). R2 is made up of multiple component technologies and systems encompassing nearly 50 patented and patent-pending technologies with the potential to be game-changers in multiple industries, including the medical industry. R2 technologies can aid in a variety of medical applications, ranging from telemedicine to handling the logistics of medical procedures. These activities can be done in autonomous mode or in teleoperation mode, where the robot is controlled by a technician or physician. This type of operation would be advantageous in situations where a biomedical hazard poses risks to humans, such as a contagious outbreak or a combat situation. For more routine daily use, R2 could function as an assistant to the hospital staff.

Posted in: Briefs, Medical, Surgical procedures, Robotics, Biohazards, Biomechanics

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