Health, Medicine, & Biotechnology

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.

Posted in: White Papers, Manufacturing & Prototyping, Medical

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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.

Posted in: White Papers, Instrumentation, Medical

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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.

Posted in: White Papers, White Papers, Aerospace, Manufacturing & Prototyping, Medical

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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.

Posted in: White Papers, White Papers, Medical

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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, Materials, Medical

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Avoiding Common Mistakes in Extractables/Leachables Program Design

Mistakes in program design for extractables/leachables testing can lead to significant delays, rounds of questions, and the need for additional testing. And, in some cases, all of the extractables/leachables testing may need to be repeated. To avoid these costly mistakes, it is important to understand the current standards as well as the current interpretations and opinions from regulators interpreting these standards. In this whitepaper the experts from WuXi AppTec discuss the current standards, interpretations and will provide you with tips to avoid common mistakes when designing your program.

Posted in: White Papers, White Papers, Medical

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Engaging stakeholders in the home medical device market

The Growing Home Medical Device Market – How Could It Impact Med Tech Stakeholders? 90% of patients prefer digital technology tools (such as mobile apps) over medication, per an October 2013 survey by Digitas Health. And, Semico Research's Aging in Place: The Internet of Things for the Golden Years forecasts that the home medical device market will reach $30 billion in revenues by 2017. Gain expert insight into engaging stakeholders of the growing home medical device market - including implications for manufacturers, intended device uses, end users, safety and essential performance, transformation requirements, mobile apps + more.

Posted in: White Papers, White Papers, Medical

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