In June 2025, the FDA released a white paper emphasizing the need for stronger cybersecurity in medical product manufacturing, specifically focusing on Operational Technology (OT). The paper, titled “Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing,” highlights how increased connectivity in manufacturing environments can create vulnerabilities if cybersecurity isn’t prioritized. The FDA urges manufacturers to adopt state-of-the-art cybersecurity practices for OT to reduce the risk of cyber incidents and ensure the safety and reliability of medical products.
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- Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
- AI Omnibus enters into force
- EU CTR Q&A Version 7.3 is Out
- New WHO guide on Artificial intelligence-related health research
- GDP for APIs: APIC Publishes Updated “How to Do” Document
- Team-NB Position Paper :TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES
- MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
- New ISO Guidance for AI-Powered Medical Devices: ISO/TS 24971-2:2026 Published!

