Tag: Medical Devices

The Impact of AI on Medical Device Technology and Certification

Medical Device

Artificial Intelligence (AI) refers to the capability of machines to perform tasks traditionally linked to human intelligence—such as perception, learning, decision-making, planning, and language processing....

AI Algorithms, AI and Data, AI Impact, AI Med Tech, Data Science, Healthcare AI, Healthcare Innovation, Machine Learning, Medical Device Certification, Medical Devices

MHRA Issues Transparency for Machine Learning and Medical Devices

Medical Device

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published guiding principles for machine learning medical devices, focusing on transparency. According to the MHRA guidance, “These...

AI, Device Performance, Digital Health, Healthcare Transparency, Innovation In Healthcare, Machine Learning, Med Tech, Medical Devices, MHRA, Regulatory Guidelines

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2024

Medical Device

USA Air-Powered Dental Handpieces and Air Motors – Updated Performance Criteria The FDA has issued guidance covering dental air-powered handpieces, air motors (product code EFB), and angle attachments...

FDA, Medical Device Compliance, Medical Devices, Performance Standards, Regulatory News, Safety Guidelines

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Aug 2024

Medical Device

USA Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers The VMSR (Voluntary Malfunction Summary Reporting) Program permits device manufacturers to report certain device...

Asia Regulations, Europe Regulations, Global Compliance, Global Regulatory Updates, Healthcare Regulations, Medical Device Regulations, Medical Devices, Regulatory Updates, USA Regulations

Medical Devices – USA, Europe and ROW Regulatory News – July 2024

Medical Device

USA Medical Device User Fee Rates for Fiscal Year 2025 The U.S. FDA has announced the fee rates and payment procedures for medical device user fees for the fiscal year (FY) 2025. This update...

Clinical Guidance, Clinical Updates, Device Regulation, Medical Devices, Medical News, Medical Regulations, Regulatory Updates

European Health Data Space’s implications for “Wellness Apps” & Medical Devices

Medical Device

European Health Data Space is a health specific ecosystem comprised of rules, common standards The European Health Data Space (EHDS) is a specialized health ecosystem built on shared rules, standards,...

AI in Healthcare, Digital Health, Electronic Health Records (EHR), GDPR Compliance, Health Data Security, HealthTech Regulations, Medical Devices, Preventive Healthcare, Wellness Apps