The European Medical Device Regulation (EU MDR) continues to pose challenges for medical device manufacturers as they strive for compliance. With...
Navigating the FDA's Latest Guidance on AI/ML in Medical Devices
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Stefanie Wichansky on Mar 17, 2025 3:40:22 PM
Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the medical device industry by enabling adaptive, data-driven...
Which QMS Certification is Right for Your Company?
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Stefanie Wichansky on Mar 17, 2025 3:30:48 PM
For medical device companies, compliance with international quality standards is essential to ensure product safety, regulatory approval, and...
Avoiding FDA Inspection Findings: A Guide for Pharmaceutical and Biotech Companies
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Stefanie Wichansky on Feb 10, 2025 4:59:21 PM
How Medical Device Companies Can Avoid FDA Inspection Findings – And the Consequences of Noncompliance
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Stefanie Wichansky on Feb 10, 2025 4:53:04 PM
For medical device companies, compliance with FDA regulations is not just a legal obligation—it is critical to ensuring patient safety, product...
Donor Eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): FDA’s Evolving Guidance
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Stefanie Wichansky on Feb 10, 2025 4:47:01 PM
The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety of Human Cells, Tissues, and Cellular and Tissue-Based...
FDA’s Perspective on AI in Drug and Biological Product Development
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Stefanie Wichansky on Feb 10, 2025 4:19:14 PM
Artificial Intelligence (AI) is rapidly transforming the pharmaceutical and biotechnology industries, offering powerful tools to accelerate drug...