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Key Takeaways –  Introduction: Did you know that around 100+ million individuals were affected by healthcare industry cyberattacks in 2023? The more surprising fact is that it doubled, as it was around 44 million in 2022. The majority of manufacturers worldwide consider cybersecurity a one-time or last-stage concern. However, the reality is little different; cybersecurity is […]

Introduction GDPR Article 32 security testing documentation requires organisations to implement technical and organisational measures, such as regular testing and evaluation of security controls. According to reports from the European Commission, more than 280,000 personal data breach notifications have recived to EU data protection authorities since May 2018. Many of these incidents happened because of […]

Key Takeaways Introduction The clock is running. The majority of responsibilities associated with the compliance of the EU AI Act, as well as the whole structure of high-risk AI systems, will become effective on 2 August 2026. The fines can be introduced by the national competent authorities of all 27 EU member states from that […]

Key Takeaways Introduction CDSCO medical device license audit is not just a document review. It is the checkpoint that determines whether the medical device manufacturer is actually operating in conformity with the Medical Devices Rules, 2017, with the audit route also depending on the class of device and licensing authority. In Class A and B […]

The agentic AI systems are AI-driven software that may independently set objectives, make decisions, and operate workflows without the involvement of humans. They are able to learn and develop themselves based on their own results. The Agentic AI systems have numerous security and compliance risks since they are able to plan and execute tasks without […]

Medical Device Cyber Risk Assessment shows that one vulnerable medical device can do better than data exposure. Thus, able to interfere with treatment, change clinical decision-making, or become a point of attack in a whole hospital system. The risk is no longer theoretical as healthcare systems are getting more interconnected. It is operational. Infusion pumps and […]

New applications are being developed and deployed more quickly than ever. This is true for cloud platforms, microservices, and automated CI/CD pipelines, which have been widely adopted. With the increased rate of development, security professionals are required to detect vulnerabilities at an earlier stage.  They need to find them within the software development lifecycle before […]

Key Takeaways Introduction If you manufacture or supply medical devices in India, regulatory expectations are already part of your daily operations. The Central Drugs Standard Control Organization governs these requirements under MDR 2017. They ensure devices meet safety and quality standards before reaching patients. Connected systems, software-driven tools, and smart healthcare technologies are now part […]

Key Takeaways India’s Digital Personal Data Protection (DPDP) Act is a current reality rather than a concern for businesses to consider in the future. There is a common myth among new businesses that being “Safe to Host” means that they are compliant as per the DPDP Act compliance for Indian businesses.  However, in reality, the […]