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FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data

By MedTech Intelligence Staff

…device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA….

…device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA….

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Doctor working on computer

Benefits and Risks of CDSS To Prevent Medication Errors and Adverse Drug Events

By MedTech Intelligence Staff

…were included in the review (27 systematic reviews, one overview of reviews, and five primary studies). Overall, computerized provider order entry with medication-related CDSSs were associated with reduced medication errors…

…were included in the review (27 systematic reviews, one overview of reviews, and five primary studies). Overall, computerized provider order entry with medication-related CDSSs were associated with reduced medication errors…

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MHRA Announces New UK Approved Bodies

By MedTech Intelligence Staff

…Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD)….

…Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD)….

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NIST Heart on a Chip

NIST Introduces Heart-on-a-Chip for Cardiovascular Research

By MedTech Intelligence Staff

…conventional cardiovascular drug development, which relies heavily on animal testing. By replicating humanlike models to study cardiovascular diseases, NIST believes the HoC system has the potential to replace animal testing,…

…conventional cardiovascular drug development, which relies heavily on animal testing. By replicating humanlike models to study cardiovascular diseases, NIST believes the HoC system has the potential to replace animal testing,…

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Randy Horton

FDA-Cleared SaMD by the Numbers

By Randy Horton

…by Company What is the breakdown of SaMD clearances among the 308 unique companies on our list? The majority of companies (73.7%) have just one clearance. Companies with two clearances…

…by Company What is the breakdown of SaMD clearances among the 308 unique companies on our list? The majority of companies (73.7%) have just one clearance. Companies with two clearances…

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Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

By Celegence

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration….

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration….

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Steve Cumper

Top 5 Safety Hazards in Medical Device Manufacturing (and How to Reduce the Risk)

companies, leading to added workers compensation and care costs, manufacturing slowdowns and diminished productivity. Organizations that prioritize worker safety not only reduce these adverse effects, they benefit from improved employee…

companies, leading to added workers compensation and care costs, manufacturing slowdowns and diminished productivity. Organizations that prioritize worker safety not only reduce these adverse effects, they benefit from improved employee…

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Registration Opens for March IMDRF Meeting in Washington, DC

By MedTech Intelligence Staff

…will be hosting this year’s session at the Ronald Reagan Building & International Trade Center in Washington, D.C., March 11-15, 2024. The free event is open to the public, virtually…

…will be hosting this year’s session at the Ronald Reagan Building & International Trade Center in Washington, D.C., March 11-15, 2024. The free event is open to the public, virtually…

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