Medical Device

Medical device manufacturers operating globally face a growing challenge: post-market surveillance systems that satisfy EU MDR requirements do not automatically meet FDA expectations under the new QMSR.

While specific requirements vary by market, it is clear that post-market surveillance limited to collection of customer complaints, or reactive post-market surveillance, is not adequate.

The regulatory framework for Software as a Medical Device (SaMD) ensures that software intended for medical purposes is safe and effective for patient use. This includes assessing risks, validating clinical effectiveness, and adhering to stringent cybersecurity standards. Navigating these regulations is critical to bringing SaMD products to market successfully.

Discover how Software as a Medical Device (SaMD) is transforming healthcare—and the regulatory complexities that come with it. This article explores key challenges, evolving global standards, and the role of AI and machine learning in SaMD development.

Substantiating the safety and performance of your medical device is the most important part of bringing a medical device to market. In the European Union (EU), the clinical evaluation report (CER) is a major component of this process.

In the European Union (EU), post-market surveillance is a crucial phase of a medical device's regulatory compliance. Learn about the three components of this framework that ensure manufacturers are properly capturing, documenting, and reporting this phase of the product lifecycle.

This article outlines the importance of systematic clinical literatures for achieving and maintaining regulatory compliance, most notably in the EU but also in other markets, which may have differing literature review requirements.

Since the early 2000s next-generation sequencing (NGS Assays) has become an invaluable tool in both drug discovery research and clinical/diagnostic settings.

Pregnancy ultrasounds are well known. Did you know that its first practical use was for detection of objects, propelled by the sinking of the Titanic in 1912?