Future-Proofing Your Program
Post-Market Security Management · 1 min read
5.13.1 Emerging Challenges
Prepare for evolving threats:
AI/ML Vulnerabilities:
- Model poisoning
- Adversarial inputs
- Privacy attacks
Supply Chain Risks:
- Deeper dependencies
- Nation-state threats
- Component transparency
Ransomware Evolution:
- Targeted attacks
- Data exfiltration
- Operational disruption
5.13.2 Regulatory Evolution
Stay ahead of requirements:
Likely Changes:
- Mandatory reporting timelines
- Stricter patch requirements
- Enhanced transparency
- Global harmonization
Preparation Steps:
- Build robust processes
- Document everything
- Exceed minimums
- Stay informed
Sources
Primary documents for the topics in this section:
- Postmarket Management of Cybersecurity in Medical Devices, FDA, December 28, 2016.
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