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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- Computer Software Assurance for Production and Quality Management System Software
- FDA CDER – 2025 New Drug Therapy Approvals: key takeaways
- The MDSAP Audit Approach (MDSAP AU P0002.010) was just revised
- FDA Clinical Decision Support Software
- FDA GUIDANCE : Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
- The FDA’s updated compliance program manual
- The FDA’s Quality Management System Regulation (QMSR) is now LIVE and fully effective
- ICH M11 guideline, clinical study protocol template and technical specifications – Scientific guideline

