Blog Post Life Sciences Medical Device Understanding Recent FDA Guidance on Firm to HCP Communications: Questions & Answers On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...
Blog Post Quality + Compliance Medical Device What You Need to Know About Recent FDA Guidance on Firm-to-HCP Communications Regarding SIUU On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...
Blog Post Quality + Compliance Medical Device PCCP for AI: The FDA’s Latest Guidance on AI in Medical Devices On December 4, 2024, the Food and Drug Administration (FDA) announced a final guidance entitled “Marketing Submission Recommendations for a ...
Blog Post Quality + Compliance Consumer Products Extending the Life of Your Aging QMS Your aging quality management system (QMS) and the problems caused by it are keeping you up at night. You would ...
Blog Post Quality + Compliance Medical Device Replacement of Title 21 CFR Part 820 with ISO 13485-2016 The wait and suspense for the United States Food and Drug Administration’s (FDA) plans to harmonize and modernize the way ...
