Achieve IEC 62304 Compliance with Bluefire Redteam
IEC 62304 is the international standard for medical device software lifecycle processes, ensuring safety, reliability, and regulatory compliance. It is a crucial framework for software development in medical devices, covering risk management, maintenance, and documentation.
Identify non-compliance areas in your software lifecycle
Assess cybersecurity risks and vulnerabilities
Define software safety classifications (Class A, B, C)
Identify security threats to medical device software
Implement best practices for medical device security
Create and maintain documentation required for compliance
Support regulatory submissions and audits
Medical device manufacturers must comply with IEC 62304 to meet regulatory requirements, such as FDA, EU MDR, and ISO 13485. Compliance helps:
Ensure patient safety by reducing software risks
Improve software development efficiency
Streamline regulatory approvals
Reduce cybersecurity threats
Ensure your medical device software meets IEC 62304 standards with Bluefire Redteam. Contact us today for a consultation and let our experts guide you toward compliance and security.