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Introduction You can do everything right on the clinical side and still watch your PMA get blocked before review even begins. That is exactly what is happening to teams that treat cybersecurity as a secondary requirement. At the Premarket Approval level, the FDA does not just evaluate whether your device works. It looks at whether […]

Germany is also among the world’s most powerful centres for medical device innovation. German companies are increasingly targeting the U.S. market; this trend reflects startups creating software-intensive medical equipment and more established companies seeking to enter new markets across the globe. The FDA is one of the most stringent regulatory organizations in the world, which […]

Introduction Cybersecurity has moved from a supporting document to a legal requirement in cyber devices related to the healthcare industry for submissions. With the introduction of Section 524B of the FD and C Act in 2023, the FDA now expects cybersecurity documentation to be complete at the time of submission; the file may be refused […]

Key Takeaways –  EU MDR software development requirements include guidelines that every medical device software needs to follow to achieve CE marking and be sold in Europe. From software design to testing, release, and post-launch monitoring, these standards include cybersecurity in every phase. Certain standards, such as IEC 62304, IEC 62443, and ISO 14971, serve […]

Key Takeaways De Novo means starting from zero. There is no predicate, so your cybersecurity baseline has to be defined and explained clearly Review decisions depend on how well things connect. Risks, controls, and testing should link together, not sit in separate sections Delays usually come from complicated documentation. Even good security work gets questioned […]

Introduction Following recent FDA QMSR updates aligned with ISO 13485, the FDA has intensified its refusal-to-accept (RTA) criteria for 510(k) submissions.  Software Bill of Materials (SBOM) or a formal Secure Product Development Framework (SPDF) is required for devices classified as ‘cyber devices’ under Section 524B. FDA and CISA advisories show a consistent trend of high-severity […]

Introduction FDA readiness means a continuous state of preparation for the USA Food and Drug Administration (FDA) inspection. It is a mandatory requirement for all kinds of organisations that are involved in manufacturing, processing, storage, distribution, or testing of FDA-regulated products, including pharmaceuticals, biologics, medical devices, dietary supplements, food, and cosmetics. Non-compliance can lead to […]

Introduction A BIMO inspection is an on-site or remote FDA inspection conducted under the Bioresearch Monitoring (BIMO) Program to audit the conduct of research for FDA-regulated products. FDA’s Bioresearch Monitoring (BIMO) is essential for protecting human subjects. It ensures credible clinical data on subjects taken for research. In 2026, BIMO inspections will no longer be […]

Key Takeaways –  ISO 14971 is a globally accepted set of standards for risk management in medical devices and healthcare software. ISO 14971 does not explicitly define cybersecurity requirements, but it applies to cybersecurity risks when they can lead to patient harm or safety issues. As per the EU MDR 2017/745, the medical device manufacturers […]