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The U.S., EU, Or U.K.: Which Medical Device Market Should I Enter First? | By Leeanne Baker, managing director and senior QA/RA consultant, IMed Consultancy | This is a time of major regulatory changes, and for many, it's been difficult to keep up. This article shares a brief overview and comparison of the regulatory frameworks in the U.S., EU, and U.K., along with key considerations to keep in mind when choosing your first market. |
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By Allan Marinelli and Howard Mann | This article, part two of a three-part series, examines the prerequisites phase, development, and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis. |
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| Validation Of Novel Identification Algorithms For Nonfatal MI | Poster | By Kayleen Ports, Weixi Chen, David Saunders, Bhargav Koduru, Jacob Aptekar, Ph.D., John Spanias, Ph.D., Caleb Strait, Ph.D., Christopher Tso, Robert Buderi, Danielle Gerome, Pierre-Louis Bourlon, Silvy Saltzman, Tanmay Jain, Aniketh Talwai, Rahul Jain, Ph.D., Dassault Systèmes | Explore findings from a study aiming to develop and validate algorithms for MI identification using pooled CT data by adapting the clinical guidelines proposed by SCTI and the FDA. |
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| Elements Of Design: Dealing With Suspect Parts | Article | Medbio | Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Learn about a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in the molding process. |
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| Tech Talk: LPD Series Dispense Pumps | Article | The Lee Company | Increasing demands on IVD instruments present many challenges for instrument designers, but selecting a dispense pump doesn’t have to be one of them. The Lee Company’s LPD Series variable volume dispense pumps feature a stepper motor driven, positive displacement design that provides unmatched performance and reliability at an economical price. |
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| Providing Superior And Secure Care With RFID Technology | White Paper | HID | Hospitals and healthcare providers are going well beyond the basics of patient care these days. Years ago, hospitals took good care of patients by providing the best quality medical care they could. Today, they’re tasked with that and so much more. |
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ARTICLES YOU MAY HAVE MISSED |
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Most medical tubing specifications comprise a drawing of a tube with the material, dimensions, and tolerances. However, parameters associated with the production of the tubing are also key. |
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