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By Will Garvin and Michael McLaughlin, Buchanan Ingersoll & Rooney | The FDA cybersecurity requirements for medical “cyber devices” went into effect on October 1, 2023. The FDA has made it clear that it cannot accept submissions that don’t meet these requirements. Here are four steps to navigate the new requirements. |
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Liquid Biopsy: The Next Evolution In Personalized Prostate Cancer Screening | By Spencer Heaton, MD, MBA, LynxDx | The prostate-specific antigen (PSA) blood test has long been the gold standard in prostate cancer diagnostics. More recently, liquid biopsy, which includes the analysis of circulating tumor material in the blood or urine, has emerged as a promising non-invasive tool. |
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| What Is An Aqueous Cleaner? | Article | By Michael Moussourakis, Jeff Phillips, Stacy Silverstein, and Malcolm McLaughlin, Alconox Inc. | This chapter of The Aqueous Cleaning Handbook explains what an aqueous cleaner is, what it contains, and how it can improve your cleaning process. |
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| Inspection Of Injectable Products For Visible Particulates | White Paper | By John Rech and Ravi Patel, West Pharmaceutical Services, Inc. | Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables. |
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| RFID For Med Devices: Identifying A Partner | White Paper | HID | RFID is increasingly being used in medical devices. Utilize this guidance on finding a suitable RFID partner, including what to look for in a supplier, case studies, and proprietary technologies. |
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ARTICLES YOU MAY HAVE MISSED |
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Additive manufacturing (AM) and micro 3D printing have disrupted the way microsized parts are designed and manufactured. Advances enable faster prototyping, faster production, more complex geometry, and smaller sizes. |
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Designed to secure tubing over hose barbs effortlessly, Pharma+ retainers feature a revolutionary lead-in ramp ensuring complete 360° compression to prevent leaks. |
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