Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.
The ASCA Pilot is intended to provide increased confidence in testing results from ASCA-accredited testing laboratories, as well as decrease the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories.
When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.
This article explains the MDD’s shortcomings, details the MDR’s history, highlights expected transition timelines, describes the most significant changes, and discusses the anticipated impact on medical device markets.
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.
Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.
PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.
At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.
Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.
The new FLIR Research Studio is a powerful, yet simple to use software for analyzing how thermal imagery changes over time. Designed to work the way you work, the software makes thermal analysis faster, more convenient, and enables better teamwork. Whether a Windows, MacOS or Linux user, Research Studio provides customers with an easy way to quickly and efficiently display, record, and analyze accurate thermal data on their machine in any one of the available 22 languages.
The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency.
Starting with the specifications phase, through design, prototypes up to volume production, the MST Group is your reliable partner for turning any of your ideas into a marketable product.
SCHOTT Lighting and Imaging specializes in design and manufacture of fiber optic, LED, optical and hybrid product solutions for use in medical, dental, scientific, industrial, defense, aviation and automotive applications. In the medical field, SCHOTT specializes in custom solutions for OEM manufacturers such as leached fiber optic image bundles and light guides for endoscopy applications, fused fiber optic tapers and faceplates for x-ray applications and flexible wound fiber bundles for MRI applications.
In the age of connectivity and precision medicine, cybersecurity has taken on critical importance in medical technology development. Software intrusions can risk patients’ health and well-being, as well as their personal data. Device designers must balance these concerns against healthcare provider and patient demand for more connectivity, more access to information, and more ease of use. In this free collection of articles, Med Device Online has collected insights from some of the cybersecurity experts among our editorial contributors.
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