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Understanding the FDA's Draft Guidance on 510(k) Transfer of Premarket Notification and Key Recommendations
The Food and Drug Administration (FDA) has recently released a draft guidance document aimed at the healthcare and medical device...
4 days ago


Understanding the Critical Role of Clinical Evaluation in Medical Device Approval Processes
The world of medical devices is rapidly evolving, bringing about remarkable advancements in how we diagnose, treat, and manage patient...
Jun 6


Essential Best Practices for Effective Post-Market Surveillance in Medical Device Companies
Post-market surveillance (PMS) is crucial for the ongoing safety and effectiveness of medical devices after they hit the market. As...
Jun 6


Inside the FDA’s AI Shift: What Life Sciences Leaders Need to Know About Elsa
On June 4, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of Elsa , a new generative artificial intelligence (AI)...
Jun 4


Decoding the New UKCA Mark: Essential Insights for Medical Device Companies
In the wake of Brexit, the United Kingdom has created its own set of rules for different industries, including medical devices. The UK...
May 29


Navigating the Future of FDA 510k Submissions Through eSTAR Insights and Implications for Regulatory Leaders
n the fast-paced world of medical device regulation, keeping up with changes is crucial. One of the most significant shifts is the FDA's introduction of the electronic Submission Template and Resource (eSTAR) for 510(k) submissions. This move aims to make the submission process smoother, increase clarity, and ultimately improve patient access to safe medical devices.
For regulatory operations and quality leaders in medical device companies, understanding eSTAR's details i
May 23


Navigating Common Pitfalls of EU MDR and How to Avoid them in 2025
The European Medical Device Regulation (EU MDR) continues to pose challenges for medical device manufacturers as they strive for compliance.
Apr 14


Which QMS Certification is Right for Your Company?
For medical device companies, compliance with international quality standards is essential to ensure product safety, regulatory approval, and market access.
Mar 17


Navigating the FDA's Latest Guidance on AI/ML in Medical Devices
Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the medical device industry by enabling adaptive, data-driven...
Mar 17


Avoiding FDA Inspection Findings: A Guide for Pharmaceutical and Biotech Companies
The pharmaceutical and biotech industries operate under intense regulatory scrutiny, with the U.S. Food and Drug Administration (FDA) ensuring compliance with Current Good Manufacturing Practices (cGMPs) and other regulatory requirements...
Feb 10


Donor Eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): FDA’s Evolving Guidance
The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) by regulating donor eligibility and screening protocols.
Feb 10


Navigating the Future: FDA’s Draft Guidance on AI-Enabled Medical Device Software
Artificial Intelligence (AI) is revolutionizing healthcare, particularly in the medical device sector.
Feb 9
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