Facilitate compliance with medical device regulatory standards
Medical devices: Regulatory standards and compliance
IBM Rational solution for medical devices
Learn about the IBM Rational medical device solution, covering the collaboration, guidance in conforming to FDA Quality System Regulation, change management and requirements management.
Three steps to rapid development of high-quality medical devices
Medical device developers face challenges that are different from developing products in most other industries. Three IBM experts describe three steps that help accelerate development, yet still produce high-quality devices that comply with regulations.
Saving you pain while you save lives
Learn how IBM Rational solutions can help you meet regulatory compliance with enhanced automation and reporting, integrated requirements and quality management and early defect detection and removal.
Security in eHealth: Designing software to connect devices safely
Learn about the issues in interoperability between embedded devices and the eHealth cloud, and what is critical to understand about embedded medical software design to ensure security is built in from the start without sacrificing capability.
Critical steps to ensuring standards compliance
Applying the latest in standards-compliant development, test and virtualization technologies can enable safer, more secure, and more reliable medical devices.
Challenges and opportunities for the medical device industry
What does IEC 62304 compliance means for manufacturers and what systems and software engineering best practices are used in many of today’s most successful companies.