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A 510(k) submission can look neat, complete, and perfectly packaged inside eSTAR, then still get slowed down by questions FDA could see coming from page one. That is the trap. FDA eSTAR gives you the structure. It tells you where to place device details, predicate information, performance data, labeling, cybersecurity evidence, and attachments. Since October […]

Medical device companies spent years working under QSR. That changed on February 2, 2026, when the FDA’s Quality Management System Regulation (QMSR), as outlined in the FDA QMSR guidance, officially took effect. For some organizations, the transition has been fairly straightforward. Others are discovering that records, supplier oversight, software validation, inspection preparation, and quality documentation […]

Cyber attacks are continuing to focus on one of the largest sectors – the healthcare industry, which accounted for nearly three-quarters of all reported hacking incidents when statistics were provided by the Department of Health and Human Services (HHS) in the first quarter of this year. More so, the Office for Civil Rights (OCR) indicates […]

For medical device companies in the USA, a weak quality management system is not just an audit problem. It can burn through capital. A MedTech startup or mid-sized division can spend close to $500,000 a month before revenue begins. If poor QMS planning leads to a failed audit, extra FDA review, or a delayed launch, […]

Most enterprises already have AI running inside their businesses. Many just don’t realise how widespread it has become. It includes the growing use of shadow AI, AI tools adopted by employees without formal oversight or approval. Palo Alto Networks found that generative AI traffic across enterprise networks grew by more than 890% during 2024 after studying usage […]

FDA says 510(k)s submitted after October 1, 2023, must be submitted electronically using eSTAR, unless exempted. This move has led to a consistent approach to data collection during the initial acceptance period, but added to the technical review burden in the substantive decision-making phase. Moreover, recent financial reports show the average Total Time to Decision […]

An fda deficiency letter can slow a submission just when your team expects movement. It can affect launch planning, testing budgets, clinical work, software evidence, cybersecurity documentation, labeling updates, and quality records in one review cycle. The term can also be confusing. The FDA does not use a single deficiency letter across every product pathway. In medical […]

According to IBM’s 2025 Cost of a Data Breach Report, 13% of organizations reported breaches involving AI models or applications. In 97% of those cases, the affected organizations said proper AI access controls were missing. Model inversion attacks are one example of the growing risks facing AI systems, allowing attackers to potentially infer sensitive information from model […]

Medical devices have changed a lot in the last few years. Many now connect with hospital networks, mobile apps, cloud platforms, and remote monitoring systems. While this has improved patient care, it has also created new security problems. Making compliance with the FDA cybersecurity checklist essential for manufacturers developing connected medical devices. Hospitals across the US have […]