Regulatory

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.

The European Union’s Regulation on Deforestation-Free Products (EUDR) is expected to impact many consumer products across the global supply chain.

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.

Pediatric medical devices are critical for proper medical care of children. The connection between innovation and realization is a challenging one.