Category: Medical Device

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

October 7, 2024
Medical Device

USA Air Powered Dental Handpieces and Air Motors – Performance Criteria for Safety and Performance Based Pathway The devices covered by this guidance include dental air-powered handpieces, air...

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

Medical Device Regulatory Challenges & Solutions | Expert Insights

September 13, 2024
Medical Device

Medical devices must meet stringent regulatory requirements to ensure safety and efficacy. These regulations are crucial but can also be complex and challenging for companies. Understanding and addressing...

Compliance Services, Device Compliance, Global Regulations, Medical Device Regulation, Regulatory Challenges, Regulatory Experts, Regulatory Solutions, Regulatory Strategy, Regulatory Updates

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

September 4, 2024
Medical Device

USA Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers The VMSR (Voluntary Malfunction Summary Reporting) Program allows 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

August 6, 2024
Medical Device

USA Medical Device User Fee Rates for Fiscal Year 2025 The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for the fiscal...

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

July 29, 2024
Medical Device

The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at: 1. Empowering individuals...

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

July 4, 2024
Medical Device

USA Guidance on Laboratory Developed Tests: Small Entity Compliance Guide FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests”...