Health, Medicine, & Biotechnology

Risky Business: Why Excluding Suppliers from Your Quality Processes Could Cost You

Suppliers play a major role in bringing products to market. This means that the product received from suppliers must be of the highest quality and level of safety possible—this is a must because stakeholders not only rely on their suppliers to help bring products to market, they also rely on them to help maintain their brand image. In this White Paper, you'll learn how to incorporate suppliers into your quality and compliance activities, resulting in a greater level of assurance.

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ISO 13485 - The Proposed Changes and What They Mean for You

How will the ISO 13485 revision's risk-based approach change your company's relationship with customers, suppliers + regulatory authorities? Gain an expert, clause-by-clause view into the revision's impact on partner roles, storage + distribution processes, reporting, documentation + more.

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Rapid PCR Instrument Development

Today, there is great demand for next-generation polymerase chain reaction (PCR)-based diagnostics for the rapid analysis of patient samples and simultaneous detection of multiple diverse markers. Generally, PCR imaging systems limit testing to one, slow PCR protocol at a time. To complete multiple independent tests requires multiple runs over several hours or even days. The solution is a new, rapid, real-time PCR instrument with multiple, randomly accessible thermal blocks and easy-to-use software that provides researchers and clinicians with flexibility in workflow with rapid results in 20 minutes.

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Parallel Prototyping and the Engineer’s Dilemma

R&D Engineers face rapidly shrinking development cycles and rising competitive pressures. In the high-stakes practice of regulatory compliance, balancing development costs with speed, safety and performance are critical to a product’s success. This paper demonstrates how the parallel prototyping of two materials in a heating component contributes to the return on investment of a new product launch in the medical device industry. The study addresses the verification, validation, form and fit testing relative to the FDA approval process, as well as its execution within component design, product design and pilot production.

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Molds for Medical Technology

The demand for productivity in the field of medical consumables is consistently growing at a rapid rate. The growth of the world’s population, expanding urbanization, aging societies, and increasing self-medication are contributing to this growing demand, despite manufacturers’ limited production space. Costs continue to rise, and manufacturers are increasingly looking at stack molds for their capability to double the output while reducing waste.

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The Truth about Parylene Coating & Medical Devices

Parylene is the generic name for members of a unique polymer series. Parylene conformal coatings represent a distinct family of organic polymeric coating materials that are polycrystalline and linear in nature, with innumerable commercial applications. Resilient, dielectric, and pinhole-free, parylenes are frequently selected for use with products subjected to ongoing conditions of duress that might otherwise diminish their performance.

Posted in: White Papers, White Papers, Coatings & Adhesives

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Assisting An Aging Population: Designing Medical Devices With Force Sensing Technology

With the geriatric population on the rise, design engineers are challenged with designing responsive, noninvasive, user-friendly medical devices that cater to the needs of an older generation. Patients are looking for cost-effective, easy to use assistive tools that help them regain independence and confidence in their everyday life. Force feedback is a key feature for many of these devices that provide the user and doctor with great insight that ultimately results in better quality of life for the patient. Medical devices with force feedback allow design engineers to create innovative products that differentiate them from the competition. 

Posted in: White Papers, White Papers, Electronics

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