Case Study of a medical device OEM start-up that selected and implemented a full-suite ERP platform with a fully native QMS, achieving ISO 13485 certification and positioning themselves to ramp up production and go to market with their product.
Whether you’re writing an IFU, label or consent form, you must write clearly and accurately,
using a combination of industry terms and clear syntax. The same holds true for the
professionally trained, experienced translator who brings industry-specific knowledge and
language expertise...
At Avantier we offer Design for Manufacturing (DFM services), optimizing product design with our extensive knowledge of manufacturing constraints, costs, and methods.
Measuring the relative concentrations of carbon monoxide, products of combustion and unburned hydrocarbons is the basis of...
Miles Products represents top United States manufacturing companies specializing in custom molded thermoplastics including insert molding, injection molding, structural foam, vacuum, forming, blow molding, & rotational molding.
Optimizing the development of your custom rubber seal can be challenging. Relying on industry specialists and considering potential manufacturing methods and production volumes will enable you to navigate the innovation process. Custom rubber seal manufacturing experts offer a great...
When it comes to support orthoses, orthopaedic technicians are
generally restricted to individual constructions, as forms, functions and material thicknesses must be configured to suit each individual patient‘s needs. When complex structures are required, traditional processes are often...
The Challenge: Avoid Unnecessary Costs and Complexity
Injected molded parts that have recessed features called undercuts are more difficult to eject during manufacturing. This adds costs and complexity to tooling, and undercuts that are too deep may be especially hard to remove. Yet, some...
Machine designers are increasingly asked to build systems that take up less space, operate on less power, and run with higher performance. Thankfully motion controls are answering the call with new motors, new sensors, and new architectures. Read on to learn about the latest developments as...
According to the U.S. Department of Agriculture (USDA), in 2019 more than 15.5 million pounds of food was recalled due to contamination with extraneous material. The average cost of these recalls is more than $10 million for communication, retrieving and handling recalled product, investigating...
Many new product designs and innovations have been restricted by the limitations of plastic injection molding and other conventional manufacturing processes. Traditional 3D printing allows engineers to design more complex geometries. However, high-volume end-use part production has not been...
Recommendations for software development due diligence for Software that is used with FDA Emergency Use Authorizations (EUA). Considerations to keep in mind if you plan to submit a De Novo/510(k) product submission to market your product when your EUA expires.
Overview of current COVID 19...
In catheter design, the functional requirements of the application allow the designer to identify performance requirements such as flexibility, lubricity, kink resistance, column or push strength, and torque transfer characteristics.
Development of an optimal catheter design requires a...
Reverse engineering using scan data involves collecting scan data and using it to create computer-aided design (CAD) data. There are several outputs for reverse engineering when using scan data. This white paper explains the differences and benefits/deficiencies of those outputs.
The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in April 2019. In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019.
Download this paper to learn more about these two changes from the...
We often get asked: “Do I need a test protocol?” or “How do I develop one?” This document outlines the common sections of a protocol. We highly recommend having test protocols in place prior to starting any study and will work with you to develop your testing strategy.
Today more value is being placed on the enhancement of medical devices through miniaturization and added capabilities such as pressure sensing components. Proper integration of a MEMS pressure sensor in a medical device requires in-depth knowledge of sensor types, capabilities, validation and...
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