Articles and Insights

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.

Scopus-based mapping of 2023–2025 research to help R&D and sustainability leaders identify universities, start-ups, and technology developers worth partnering with.

Innovative molecule development relies on a thorough understanding of existing chemical IP. Nerac provides expert analysis of substructure and Markush claims to support informed R&D and patent strategies.

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.