The life sciences industry is evolving rapidly, driven by advances in technology, the globalization of markets, and increasingly complex regulatory landscapes.

The life sciences industry is entering a new era, shaped by rapid advancements in technology, evolving regulatory landscapes, and growing societal demands.

Artificial Intelligence (AI) has become a transformative tool in the life sciences industry, revolutionizing how Regulatory and Quality Compliance tasks are managed.

n the highly regulated landscape of life sciences, the role of regulatory affairs can often seem like a burden to innovation.

The appointment of Robert F. Kennedy Jr. (RFK Jr.) to a significant role in U.S. health policy could result in a major shift in regulatory and operational priorities for life sciences companies.

In 2024, medical device recalls have remained a crucial mechanism for maintaining patient safety and regulatory compliance.

Bringing a medical device to market requires more than innovation; it demands navigating complex regulatory frameworks, which vary significantly across regions.

As pharmaceutical and biotech companies strive to meet evolving FDA standards, they encounter rigorous inspections aimed at ensuring quality, safety, and compliance.

As healthcare technology continues to evolve, medical devices are increasingly connected to networks, patients, and other devices, making them susceptible to cybersecurity threats.

In 2024, the FDA remains focused on ensuring that medical device companies adhere to stringent regulatory requirements to guarantee patient safety and product quality.

Cybersecurity continues to evolve throughout all facets of the business world, and the medical device industry has taken notice.

Effective communication of information regarding drug interactions is vital to ensure appropriate use of pharmaceuticals and optimal decision-making by practitioners.

The FDA recently published four Final Guidance documents for medical devices involving dental-related products. These guidance documents cover the criteria for utilization of the Safety and Performance Based Pathway.

As the U.S. election approaches, industries closely regulated by federal agencies, like the medical device sector, are keenly watching for potential shifts in FDA regulations.

The FDA's release of the final guidance on marketing submission recommendations for Predetermined Change Control Plans (PCCPs) in AI-enabled device software represents a significant milestone in the regulation of advanced medical technologies.

Investigational devices are medical devices that are still undergoing evaluation and have not yet received regulatory approval or clearance from agencies like the FDA.

In medical device manufacturing, a robust Risk Management Plan (RMP) is essential to ensure the safety and efficacy of devices across their lifecycle.

On October 10, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) published its annual list of guidance document priorities for the upcoming 2025 fiscal year.

For medical device companies, selecting the first market for regulatory clearance is a pivotal decision.

On September 20, 2024, FDA released draft guidance titled “Chemical Analysis for Biocompatibility Assessment of Medical devices”.