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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 vulnerabilities […]

Introduction FDA Inspection 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 […]

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 limited […]

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, medical device manufacturers need […]

In 2026, payment systems are in constant hunt for cybercriminals. They leak 18 million U.S. cards every year, and they inflict damage in the tune of approximately $6.2 million per attack. Fifty percent of the businesses fail PCI DSS examinations and may be fined up to 100,000 dollars monthly. Analysts caution that the next increase […]

Key Takeaways Software is a Regulated Product. Once your code diagnoses or treats a condition, it is no longer just health tech. It is a medical device under CDSCO and must meet strict MD-14 rules for SaMD compliance with CDSCO. Risk Dictates Your Roadmap. Your regulatory burden depends on your Risk Class from A to […]

Key Takeaways “State of the art” in EU MDR cybersecurity is not about using the latest technology. It is about using what is currently accepted, proven, and defensible during review Cybersecurity is directly tied to Annex I, which means it impacts both patient safety and CE certification outcomes Standards help structure your approach, but they […]

Inroduction In 2026, healthcare institutions and clinics are at a huge risk of potential cyber threats. As per the market report, the average data breach in the medical sector accounts for around $7.42 million per incident. This is huge when compared to the investment in cybersecurity practices to deal with healthcare data breaches.   Now, the […]

Key Takeaways Traditional pentest reports fail because they lack clarity, evidence, and compliance mapping. Compliance-ready pentest reports for auditors provide clear proof, traceability, and control mapping. Audit-ready pentest report includes scope, methodology, findings, remediation, and retesting. Qualysec combines human-led testing, actionable remediation, and formal attestation. Introduction  Many traditional penetration testing reports fail when they reach […]