Category: Medical Device

Streamlining Global Market Access with Medical Device Registration

November 19, 2024
Medical Device

Expanding into international markets is a significant milestone for medical device manufacturers. However, achieving global market access comes with its share of challenges—particularly meeting medical...

Compliance Management, Compliance Solutions, Global Market Access, Healthcare Innovation, Medical Device Compliance, Medical Device Registration, MedTech Solutions, Regulatory Intelligence, Regulatory Requirements

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

November 6, 2024
Medical Device

USA Guidance on Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development The guidance provides a framework for determining whether, and what...

Asia Medical News, EU Regulations, Global Compliance, Healthcare Standards, Medical Device News, Medical Devices, Regulatory Updates, USA Medical Regulations

The Impact of AI on Medical Device Technology and Certification

October 16, 2024
Medical Device

Currently, AI refers to the ability of machines to perform cognitive tasks commonly associated with human intelligence including perception, learning, reasoning, planning, speech and language, and...

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

October 16, 2024
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, Medical Devices, MHRA, Regulatory Guidelines

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