Health, Medicine, & Biotechnology

Coming Soon - Current and Emerging Regulations for the Sterilization of Medical Devices

Specific to Ethylene Oxide, ISO11135:2014 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) transition period has expired and is now fully in effect. In this Webinar, consultants will address the upcoming Amendment to Annex E, the methodology for Single Batch Release. Also reviewed will be relevant ISO committee activities and the status of ISO10993/7 (Biological evaluation of medical devices -- Ethylene oxide sterilization residuals), and emerging regulations relating to personnel exposure to EO.

Posted in: Webinars, Upcoming Webinars, Medical
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Coming Soon - Advanced Catheter Manufacturing with Liquid Crystal Polymer Monofilament

The development of minimally invasive surgical technologies has revolutionized healthcare by making possible a growing variety of complex cardiovascular and neurological interventions that would otherwise be unthinkable. But using the body’s vascular system like a network of access routes is not without challenges—including especially the need for intravascular access catheters that can be used in interventional procedures relying on magnetic resonance imaging.

Posted in: Webinars, Upcoming Webinars, Medical
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A Balancing Act: How Months in Space Impact Astronauts' Performance

When you arrive back on Earth after a year in space, you’re going to feel it.

NASA and Jacob Bloomberg, senior scientist in the Houston, TX- headquartered Johnson Space Center, have been trying to quantify exactly what those effects will be — and how 12 months of microgravity impact an astronaut’s ability to perform simple operational tasks like opening a hatch or climbing a ladder.

Posted in: News, Patient Monitoring, Monitoring
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Product Centric QMS: A Critical Advantage for Regulated Companies

FDA regulated companies must establish quality systems for compliance. Most quality management systems (QMS) were developed to help comply with regulations with a sole focus on automating the paper-based processes around quality.

Posted in: White Papers, White Papers, Bio-Medical, Medical
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Wired for Success: Advanced Materials for Next-Gen Medical Devices

Advances in material science enable engineers to develop better solutions to design challenges, and Fort Wayne Metals has long been on the forefront on developing improved materials.

Posted in: Webinars, Upcoming Webinars, Medical
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Lipid-Resistant Component Options for IV Applications

Treatment in the ICU and OR frequently involves the use of lipids and other aggressive substances that can cause cracks Environmental stress cracking is a leading cause of plastic part failure which may lead to serious patient injury and jeopardize medical professionals. Therefore, having lipid-resistant components is essential to optimal patient care.

Posted in: White Papers, White Papers, Bio-Medical, Medical
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National Institutes of Health

The National Institutes of Health (NIH) traces its roots to 1887, when a one-room laboratory was created within the Marine Hospital Service (MHS), the predecessor agency to the U.S. Public Health Service (PHS). An agency of the Department of Health and Human Services, today NIH is the nation’s focal point for health research. Francis S. Collins, M.D., Ph.D., officially became director of NIH in 2009.

Posted in: Articles, Medical
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Surface Texturing for Improved Medical Device Strength

Today’s implantables are highly engineered assemblies with multiple complex elements that require innovative materials and sophisticated manufacturing. The development and use of new and novel materials and processes have enabled advances in both medical device performance and patient safety. Whether it’s a lighter material, a smoother surface, or a process that can be made automated and repeatable, advanced technologies such as scratch-free surfaces or specialized coatings for stimulation can help you extend or improve the life of your implantable device.

Posted in: Tech Talks, Tech Talks, Medical
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Testing the Requirements

You can’t always visualize how a system will run just by reading requirements. That’s why early testing of requirements is such a powerful technique for catching ambiguities and errors.

Posted in: White Papers, Aerospace, Automotive, Medical
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Tissue Repair, With a Single Touch

Researchers at The Ohio State University Wexner Medical Center and Ohio State’s College of Engineering have developed a new kind of TNT — a "Tissue Nanotransfection" device that generates specific cell types for treatment within a patient’s own body. The “cuff-link”-sized technology supports the repair or restoration of aging tissue, including organs, blood vessels, and nerve cells. Tech Briefs spoke with one of the TNT’s lead researchers.

Posted in: News, News, Implants & Prosthetics, Patient Monitoring, Rehabilitation & Physical Therapy
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