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Volume 16 Issue No. 13 |
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By Philip Remedios and Renée Bailey, BlackHägen Designs Implementing a hybrid work environment with R&D teams yields significant benefits but also presents challenges. In this article, we explore how to achieve successful R&D programs within the context of hybrid environments, and share key strategies and best practices to effectively navigate the challenges, including the safeguarding of sensitive information and data. |
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Medical Device Regulatory Intelligence Summit June 3-5, Washington DC 3 days of Industry Intelligence, Case Studies, and Networking with Industry Leaders. Day 1: Hands-on pre-conference workshops
Day 2: Regulatory Intelligence & Digital Transformation: understand key trends, challenges, and solutions impacting MedTech regulatory processes and MedDevice compliance. Day 3: Regulatory Efficiency: Global Compliance Intelligence, Strategies & Execution by Region. |
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| Featured Articles |
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FDA Proposes to Ban Electrical Stimulation Devices By MedTech Intelligence Staff “These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.” |
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IQ OQ PQ and Its Role in Labeling System Validation By Nick Recht, TEKLYNX “Artificial Intelligence and Medical Products: How CBER, CDER, CDRdH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development. |
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Stryker Completes Acquisition of SERF SAS By MedTech Intelligence Staff With more than 50 years in the medical device space, SERF SAS is recognized for its innovations in hip implants, including the invention of the original Dual Mobility Cup. |
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Abiomed Updates IFU for Impella Left Sided Blood Pumps Due to Perforation Risks By MedTech Intelligence Staff Use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. To date, there have been 129 reported serious injuries, including 49 reports of death. |
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Breath-based Analysis: By Karim Aly, Noze Traditional screening tests suffer from a range of challenges. From logistical barriers to concerns regarding accuracy and reliability, achieving accurate diagnosis is frequently arduous. Imagine a revolutionary approach where early disease screening becomes as simple as collecting a breath sample. Thanks to cutting-edge sensor technology and advanced artificial intelligence, this vision is now on the brink of realization. |
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FEATURED LEARNING RESOURCE |
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Discover what to consider when designing and manufacturing point-of-care diagnostic devices, including ensuring measurement accuracy and reliability, user-friendly operation, and scalable production with validated manufacturing processes. |
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| MedTech Library | |
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| Upcoming Events & Webinars |
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April 9, 2024 - 2:00PM - 3:00PM ET |
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June 3-5, 2024 |
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