Medical Device Registration in Mexico with COFEPRIS
Navigating medical device registration in Mexico with the Federal Commission for Protection against Health Risks (COFEPRIS) can be challenging for…
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eSTAR Guidelines for Successful FDA Submissions
All medical devices seeking to market into the US may require multiple submissions of various types to the Food and…
AI and Machine Learning in Medical Device Regulatory Compliance
Artificial intelligence (AI) and Machine Learning in regulatory compliance is a rapidly advancing field within the science and technology sector.
Navigating Compliance with AI and Machine Learning in SaMD
The medical device industry continues to grow and evolve, becoming increasingly reliant on technology, making software a crucial component of…
ISO 13485 Medical Devices: Global Regulatory Compliance
ISO 13485:2016 standards play a fundamental role in global regulatory compliance for medical devices. Nearly 30 years after the initial…
The MDR Transition: Key Insights for MDR Certification Renewal
During RAPS Convergence 2024, one of the main topics on the agenda was the status of the transition from MDD…
Great Britain Medical Device Registration
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), under the jurisdiction of the UK Department of Health and…
Understanding the Role of Notified Bodies in MDR Compliance
Similar to the role of Economic Operators, it is important to recognize that Regulation (EU) 2017/745 (MDR) includes a…
The Essential Guide to EU MDR Medical Device Classification
Early device classification is essential, especially if you have a complex…
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