Recentes

• 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