Manufacturing & Prototyping

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


4D Printing: New dimension for additive manufacturing

A team of Lawrence Livermore National Laboratory researchers have demonstrated the 3D printing of shape-shifting structures that can fold or unfold to reshape themselves when exposed to heat or electricity. The micro-architected structures are fabricated from a conductive, environmentally responsive polymer ink developed at the lab.Scientists and engineers revealed their strategy for creating boxes, spirals, and spheres from shape memory polymers (SMPs), bio-based "smart" materials that exhibit shape changes when resistively heated or when exposed to the appropriate temperature. While the approach of using responsive materials in 3D printing, often known as 4D printing, is not new, LLNL researchers are the first to combine the process of 3D printing and subsequent folding (via origami methods) with conductive smart materials to build complex structures.The researchers create primary shapes from an ink made from soybean oil, additional co-polymers, and carbon nanofibers and "program" them into a temporary shape at an engineered temperature determined by chemical composition. Then the shape-morphing effect is induced by ambient heat or by heating the material with an electrical current, which reverts the part's temporary shape back to its original shape."It's like baking a cake," said Jennifer Rodriguez, a postdoc in LLNL's Materials Engineering Division. "You take the part out of the oven before it's done and set the permanent structure of the part by folding or twisting after an initial gelling of the polymer."Ultimately, Rodriguez said, researchers can use the materials to create extremely complex parts. "If we printed a part out of multiple versions of these formulations, with different transition temperatures, and run it through a heating ramp, they would expand in a segmented fashion and unpack into something much more complex."Through a direct-ink writing 3D printing process, the team produced several types of structures: a bent conductive device that morphed to a straight device when exposed to an electric current or heat, a collapsed stent that expanded after being exposed to heat, and boxes that either opened or closed when heated.The technology, the researchers said, could have applications in the medical field, in aerospace (in solar arrays or antennae that can unfold), as well as flexible circuits and robotic devices.

Posted in: News, Manufacturing & Prototyping


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


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, Machinery & Automation


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


Simulating Composite Structures

Layered composites are often the materials of choice when a manufacturer must reduce the weight (lightweight) of a component or system to increase fuel efficiency while maintaining strength. Composites are often used in automobiles, aircraft, ships and wind turbines for this purpose. But because their strength and performance depend upon the thickness, layer structure, orientation and other factors, determining how composite structures will perform in real-world conditions is not as easy as it is for metallic components of the same shape. Read this white paper to learn how you can use ANSYS Composite PrepPost to perform layup simulations to optimize composites for strength, durability and light weight.

Posted in: White Papers, Manufacturing & Prototyping, Composites, Materials


Reticulated Foams Expand The Boundaries Of Cellular Solids

Ideally suited for high-tech applications, reticulated foams of ceramic or metal provide industry as well as the research community with an extraordinarily versatile material form that can be engineered for particular properties and tailored for specific applications. The interconnected lattice of continuous ligaments within the cellular structure provides greater strength than shorter fibers and also ensures uniform material characteristics throughout the structure.

Posted in: White Papers, Defense, Manufacturing & Prototyping, Coatings & Adhesives, Materials


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