Terry

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.

Starting February 2, 2026, the FDA will require all medical devices sold in the U.S. to comply with the new Quality Management System Regulation (QMSR), aligning with ISO 13485:2016. This update emphasizes a risk-based approach to product compliance, ensuring enhanced safety and efficacy. Clinical data will play a crucial role in meeting these standards by guiding design improvements, risk management, and regulatory submissions.

3D technology has progressively advanced to the point where the creation of intricate surface structures that replicate bone characteristics is possible.

Market evaluation is a critical process for businesses of all sizes to assess the potential success of a service or product in a specific market. This process equips businesses to understand market dynamics, identify opportunities, and make informed decisions based on data-driven insights.

Patent pruning is an essential business strategy for companies looking to eliminate and manage their patent portfolios. The process helps businesses eliminate patents with no significant value, reduce maintenance costs, and achieve a competitive advantage in their market.