Overview of the IVD regulatory landscape in Brazil
Learn more about the IVD regulatory landscape in Brazil.
An Exciting Year of Human Factors Engineering (HFE) Regulatory Updates
2024 was an exciting year for Human Factors Engineering (HFE) with regulatory updates from the United States of America’s Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This article provides an overview of these important regulatory updates and highlights resources to help you understand their requirements.
Public Database for Clinical Investigation Report and Summaries
Some manufacturers have already completed clinical investigations and are required by regulations to store the report. The European Commission (EC) has created a dedicated public CIRCABC directory called “MDR Clinical Investigation reports and their summaries."
EU MDR Conformity Assessment Options for Medical Devices
Learn more about the EU MDR conformity assessment options for your medical devices.
Gradual roll-out of EUDAMED
When to expect the first modules of EUDAMED to become mandatory for medical devices and IVDs in the EU.
Medical Device Regulations in China
Are you seeking new opportunities for your healthcare devices? This whitepaper outlines the latest requirements for successful market entry in China.
When to Verify Risk Control Measures as Part of Human Factors Engineering Activities
Understand when to verify risk control measures in HF validation testing and how they align with URRA and FDA guidelines for medical devices.
What Does it Mean for a Device to be Inherently Safe by Design?
In this article, we discuss what is meant by safety by design, provide examples of products that demonstrate it and explore how it can be implemented within medical device design.
The Role of AI in the Practice of Human Factors Engineering
Explore the role of AI in human factors engineering for the design and development of medical devices and technologies.
MHRA Proposes International Reliance Route for Medical Devices
The U.K. MHRA proposes introducing international reliance routes for medical devices placed on the Great Britain (GB) market and seeks input from the public.