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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