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By David Elder, ELIQUENT Life Sciences | Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities. | |
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By Mark F. Witcher, Ph.D., biopharma operations subject matter expert | The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence. | |
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By Samir A. Shah, Ph.D., Devices and Digital Therapeutics, CMC Regulatory Affairs, AstraZeneca | Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access. | |
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| What Factors Impact Quality For Medical Device Manufacturers? | Q&A | Pharma & MedTech Partner Division, B. Braun Medical Inc. | This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more. |
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| Redefining Prefillable Syringe System | Infographic | West Pharmaceutical Services, Inc. | This step-by-step flow helps guide teams from early feasibility assessments all the way through to regulatory submission, with greater clarity at each stage. |
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