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01\/30\/2025 - EU MDR Compliance Benefit-Risk Analysis, AI in New Medicines, Top 5 ISO 13485 NCs \u2013 Quality Digest #197<\/a><\/div>
01\/23\/2025 - FDA Inspection Readiness in 2025, cGMP "Special AI Agent", and More - Quality Digest #196<\/a><\/div>
01\/16\/2025 - Sterility Assurance, Future-Proofing Operational Processes, and More - Quality Digest #195<\/a><\/div>
01\/09\/2025 - Supplier Audit Reports, Establishing a Win-Win Relationship With the CDMO, and More - Quality Digest #194<\/a><\/div>
12\/19\/2024 - Overcoming EU Medical Device Market Challenges, Choosing a CDMO for Early-Stage CGT, and More \u2013 Quality Digest #193<\/a><\/div>
12\/12\/2024 - Regulatory Focus Areas For Medical Device Compliance, Drug Delivery Topics, and More - Quality Digest #192<\/a><\/div>
12\/05\/2024 - FDA's Controversial Rule On LDTs, 2024 Lab Survey Findings, and More - Quality Digest #191<\/a><\/div>
11\/28\/2024 - Computer Systems Validation Execution Inconsistencies, Laboratory Developed Tests (LDTs), and More - Quality Digest #190<\/a><\/div>
11\/21\/2024 - EU AI Act Impact on Medical Device Manufacturers, Potency Assurance of CGT Products, and More - Quality Digest #189<\/a><\/div>
11\/14\/2024 - Bottleneck For EU MDR Approvals, CDMO Selection Process, and More - Quality Digest #188<\/a><\/div><\/div>");