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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- EMA Updates Guidance on National Pharmacovigilance Contact Person Requirements
- ICH E20 draft guideline on adaptive designs in confirmatory clinical trials
- Critical shortages of medicines. European Court of Auditors’ Special Report
- EDQM publishes new guidelines on the classification of active pharmaceutical substances as regards their supply
- Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR). MEDTECH E-BOOK
- A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
- Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Version 4 – September 2025
- ICH adopts M14 guideline on observational studies